[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohn-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohn-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,161,0,25,[9,42,72,93,115,149,175,202,223,244,279,307,329,352,371,389,412,430,450,469,489,509,524,545,577],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100634559","a-real-world-study-of-guselkumab-in-ulcerative-colitis-and-crohns-disease-in-saudi-arabia-100634559",false,"NCT07541261","A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia","A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia","EAGLE","Inclusion Criteria:\n\n* The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent\n* The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records\n* The participant must sign a participation agreement\u002Finformed consent form (ICF) allowing source data verification\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent","ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","OBSERVATIONAL","The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[26,27,28],"Colitis","Ulcerative","Crohn Disease","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-05-12",{"date":37,"type":22},"2029-01-29",{"name":39,"class":40},"Janssen Research & Development, LLC","INDUSTRY",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":41},"100628048","developing-a-self-management-intervention-to-improve-health-outcomes-for-patients-with-inflammatory-bowel-disease-100628048","NCT07456566","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial","Inclusion Criteria:\n\n* Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD\n* Impaired health-related quality of life\n* Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)\n* Fecal calprotectin \\> 250 microgram (ug\u002Fg)\n* Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60\n\nExclusion Criteria:\n\n* Unable to speak and read English\n* Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components\n* Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses\n* Are planned for imminent surgery\n* Have short bowel syndrome\n* Uncontrolled medical or psychiatric disease",{"count":50,"type":22},40,"INTERVENTIONAL",[53],"NA","This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.\n\nThe study team hypothesizes:\n\n* the study will achieve a recruitment rate of 10 participants every 3 months\n* 70% participant retention at 24 weeks\n* 70% outcome data collection\n* 70% intervention completion\n* high acceptability",[56,57,28],"Inflammatory Bowel Diseases","Ulcerative Colitis",[59,60,61,62],"Digital self-management program","Standard of care","Randomization","Questionnaires","NOT_YET_RECRUITING",{"date":32,"type":33},{"date":66,"type":22},"2026-07",{"date":68,"type":22},"2028-03",{"name":70,"class":71},"University of Michigan","OTHER",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100645383","retrospective-observational-multicenter-study-on-the-treatment-patterns-extra-intestinal-manifestations-resource-utilisation-and-outcomes-of-patients-with-inflammatory-bowel-disease-in-dutch-hospitals-100645383","NCT07682038","Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals","Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals","Inclusion Criteria:\n\n* Adult patients (≥18 years of age) who required secondary (hospital) care after January 2018 with a confirmed diagnosis of CD or UC, defined by at least one ICD-10 diagnosis code for CD or UC (K50, K51, K52).\n\nIndex date confirmation: the index date is defined as the first date of confirmed CD or UC diagnosis, requiring at least one healthcare encounter for CD or UC AND at least one prescription or dispensing record for any CD or UC-related medication within the observational period.\n\nExclusion Criteria:\n\n* Patients who have formally objected to the use of their hospital data for scientific research purposes. Objections are recorded by the treating hospital in the DBC administrative system and automatically transferred to the research dataset, ensuring automatic exclusion from all analyses.",{"count":80,"type":22},3500,"This multicenter retrospective real-world data study will evaluate the treatment pathways and disease burden of adult patients with Crohn's disease (CD) and ulcerative colitis (UC) treated in 5-10 Dutch hospitals between 2018 and 2026.\n\nThe study will assess:\n\n* Treatment sequences, switching patterns, and treatment duration\n* Prevalence and incidence of extra-intestinal manifestations (EIMs)\n* Healthcare resource utilization (hospitalizations, outpatient visits, endoscopies, surgery, and length of stay)\n* Direct healthcare costs\n* Availability of disease activity biomarkers\n\nUsing linked administrative, prescription, procedure, and laboratory data, outcomes will be analyzed by age, line of therapy, and clinical characteristics. Special focus will be placed on the impact of EIMs on treatment patterns, healthcare utilization, and costs.\n\nThe findings will provide real-world evidence on IBD management in the Netherlands and support clinical decision-making, healthcare planning, and future research on treatment optimization and coexisting immune-mediated conditions.",[28,83,84],"Inflammatory Bowel Disease (IBD)","Colitis Ulcerative","2026-06-26",{"date":32,"type":33},{"date":88,"type":22},"2026-08-01",{"date":90,"type":22},"2027-06-30",{"name":92,"class":40},"LOGEX",{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":41},"100514114","study-on-the-treatment-of-anal-fistulas-using-alofisel-versus-fat-autologous-stem-cells-100514114","NCT05974280","Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells","Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells","CHAZAM","Inclusion Criteria:\n\n* Complex anal fistula with the following criteria: - Inactive\u002Fslightly active luminal Crohn's disease under conventional treatment or biotherapy MRI has demonstrated effective drainage. Maximum of two internal orifices and three external orifices; persists despite internal orifice(s) closing.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Patients hypersensitive to the product, bovine serum or any of the excipients of Alofisel\n* Vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc.",{"count":102,"type":22},20,"One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells.\n\nThe current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy.\n\nThis brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed.\n\nOnly one of the two patients receives therapy; the other serves as the backup patient. By doing this, another \"back-up\" patient who might receive no care at all is avoided.\n\nAn developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities.\n\nWe would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.",[28,105],"Anal Fistula","2026-06-23",{"date":108,"type":33},"2026-06-24",{"date":110,"type":33},"2024-01-02",{"date":112,"type":22},"2027-06-02",{"name":114,"class":71},"Nantes University Hospital",{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":51,"phases":126,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100626308","partial-enteral-nutrition-to-prevent-weight-loss-and-sarcopenia-in-ibd-patients-at-nutritional-risk---simba-100626308","NCT07433946","Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA","Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA","SIMBA","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Crohn's Disease or Ulcerative Colitis\n* At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)\n* Ability to provide informed consent\n* Women of childbearing potential must use effective contraception\n\nExclusion Criteria:\n\n* Following an exclusion diet (CDED)\n* Current hospitalization\n* Pregnancy\n* Requirement for a low-protein diet","65 Years",{"count":125,"type":22},146,[53],"This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers.\n\nIBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk.\n\nParticipants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal\u002Fday) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA\u002FBIVA, vitamin B12\u002FD, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score).\n\nThe study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.",[129,28,130,131],"Ulcerative Colitis (Disorder)","Malnutrition or Risk of Malnutrition","IBD",[131,133,134,135,136,137,138],"Malnutrition","Sarcopenia","ONS","enteral nutrition","weight loss","clinical nutrition","2026-06-22",{"date":141,"type":33},"2026-06-25",{"date":143,"type":33},"2026-03-09",{"date":145,"type":22},"2027-01-31",{"name":147,"class":40},"Lionhealth Srl Società Benefit",4,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":51,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":41},"100484145","medical-treatment-versus-surgery-in-stricturing-small-bowel-crohns-disease-100484145","NCT05584228","Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease","SyMptomAtic Stricturing Small Bowel CRohn's Disease - Medical Treatment Versus Surgery, a Prospective, Multi-centre, Randomized, Non-inferiority Trial","SMART","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Male or female\n* Documented small bowel CD with intestinal stricture(s) identified on CT, MRI or endoscopy, AND responsible for obstructive symptoms\n* CREOLE score \\> 2\n\nExclusion Criteria:\n\n* Adults under guardianship, safeguard justice or trusteeship\n* Pregnant or breastfeeding female\n* Acute bowel obstruction requiring urgent surgical intervention\n* Suspected or confirmed gastrointestinal perforation\n* Concurrent active perianal sepsis\n* Internal fistulizing disease in association with strictures\n* Colonic stenosis and\u002For colonic active disease at screening endoscopy\n* Contra-indication to surgery, general anesthesia, anti-TNF, thiopurines\n* Use of corticosteroids (prednisolone \\> 20 mg daily or equivalent) within 4 weeks prior to visit V0\n* Treatment with any biologics within 8 weeks before visit V0\n* Presence of a stoma\n* HIV\u002FHCV\u002FHBV infection","70 Years",{"count":159,"type":22},150,[53],"The objective of the SMART trial is to compare a combination therapy using azathioprine and subcutaneous infliximab versus ileocecal resection in patients with symptomatic small bowel Crohn's disease.",[28],[164,165,166,167,168],"Crohn's disease","stricture","resection","infliximab","azathioprine",{"date":106,"type":33},{"date":171,"type":22},"2026-10-01",{"date":173,"type":22},"2031-04-01",{"name":114,"class":71},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":182,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":51,"phases":185,"briefSummary":186,"conditions":187,"keywords":190,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100531249","gastro-intestinal-biopotential-recorder-by-means-of-surface-electrodes-100531249","NCT06197334","Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes","GRELE","Inclusion Criteria for all participants:\n\n* Person age \\> 18 years\n* Person has been fasting for at least 12 hours\n* Person who has received full information on the organization of the research and has not objected to the use of this data.\n* Person affiliated to or beneficiary of a social security plan\n* Person informed about study organization and having signed the informed consent\n\nInclusion Criteria for healthy volunteers :\n\n* Person has no history of chronic gastro-intestinal disease\n* Person has no acute of gastro-intestinal disease\n\nInclusion Criteria for Crohn's disease patients without fibrosis :\n\n* Person is already diagnosed with Crohn's disease\n* Person has underwent during the last 6 months :\n* An MRI showing no fibrosis\n* A blood test for C-reactive protein and fecal calprotectine\n* A questionnaire to asses the Harvey-Bradshaw Index\n\nInclusion Criteria for Crohn's disease patients with fibrosis :\n\n* Person is already diagnosed with Crohn's disease\n* Person has underwent during the last 6 months :\n* An MRI showing fibrosis\n* A blood test for C-reactive protein and fecal calprotectine\n* A questionnaire to asses the Harvey-Bradshaw Index\n\nInclusion Criteria for functional gastrointestinal disorders patients :\n\n* Person is already diagnosed with functional gastrointestinal disorders\n* Person has underwent an evaluation of the Rome IV criteria\n\nExclusion Criteria for all participants:\n\n* Person having a pacemaker\n* Person suffering from a sensory disorder making insensitive to pain on the skin\n* Person suffering from a mental or motor disorders creating uncontroled movements\n* Person being allergic to one or more component of the device\n* Person being allergic to : soy, dairy food, peanuts, wheat, nuts\n* Person having an history of gastro-intestinal surgery\n* Person suffering from injury or erythema on the abdominal skin\n* Person having a contagious potential (bacterial, fungal or viral)\n* Person being in menstruation period\n* Person suffering from urinary incontinence\n* Minor (not emancipated)\n* Person of legal age (subject to a legal protection measure)\n* Adult unable to give consent",true,{"count":184,"type":22},60,[53],"The goal of this clinical trial is to compare the gastro-intestinal biopotentials recorded with a homemade device using surface electrodes placed on the abdomen in healthy volunteers, Crohn's disease patients without fibrosis, Crohn's disease patients with fibrosis and in functional gastrointestinal disorders (FGID) patients.\n\nThe main question it aims to answer is:\n\n• Is there any differences in the gastro-intestinal biopotentials between the different populations under study?\n\nIt aims to answer two secondary questions:\n\n* Are the gastro-intestinal biopotentials comparable to the Harvey-Bradshaw Index, MRI and biological data for patients with Crohn's disease?\n* Are the gastro-intestinal biopotentials comparable to Rome IV criteria for functional gastrointestinal disorders patients?\n\nParticipants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, the participants will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.",[28,188,189],"Functional Gastrointestinal Disorders","Healthy",[191,192],"Medical device","Electrophysiology","2026-06-19",{"date":108,"type":33},{"date":196,"type":33},"2025-02-18",{"date":198,"type":22},"2027-09-01",{"name":200,"class":71},"Central Hospital, Nancy, France",2,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":51,"phases":211,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":201},"100564623","phase-2-standardized-microbiota-transplant-therapy-in-crohns-disease-100564623","NCT06631586","Standardized Microbiota Transplant Therapy in Crohn's Disease","Inclusion Criteria:\n\n* Able and willing to provide informed consent.\n* 18-89 years of age.\n* English speaking.\n* Diagnosis of CD based on typical clinical and histologic features.\n* Active disease on endoscopy:\n\n  * SES-CD \\>= 6\n  * SES-CD \\>= 4 for isolated ileal disease\n* Current CD therapies are in the maintenance phase of dosing at the time of randomization.\n* Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeks prior to randomization and remain stable over study course.\n* Steroid use 20mg or less by 5 days prior to randomization.\n* Steroid use stipulations:\n* Prednisone must be tapered below 20mg after 7 days.\n* Any use of budesonide over the study period is allowed although tapering is encouraged.\n* Rescue medications: Steroid courses (up to 40mg for two weeks with a planned taper) are allowed at the discretion of the treating provider. Study drug therapy will be stopped on a case-by-case basis on discussion with the participant and treating provider.\n* Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g., absence of ovaries and\u002For uterus) must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device).\n\n  o Periodic abstinence and early withdraw are not acceptable methods.\n* Able to comply with study measures in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.\n* Documented gastroparesis\n* History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.\n* Symptomatic stricture defined as a stricture that:\n\n  * Cannot be traversed by the colonoscope,\n  * Requires intervention to be traversed,\n  * Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator.\n* Presence of ileostomy or colostomy.\n* Entero-vesicular fistula (i.e., fistula from bowel to bladder).\n* Suspicion of ischemic colitis, radiation colitis or microscopic colitis.\n* Diagnosis of ulcerative colitis.\n* Active or untreated infection.\n* Adenomatous polyps that have not been removed.\n* Use of antibiotics within 14-days of randomization.\n* Current pregnancy.\n* Current breastfeeding or planning to breastfeed over the study period.\n* History of anaphylactic food allergies.\n* End stage liver disease or cirrhosis.\n* Anticipated need for antibiotics over the study period.\n* Anticipated surgical procedure over the study period.\n* An absolute neutrophil count \\\u003C500 cell\u002FµL.\n* Diagnosis of a primary immunodeficiency.\n* Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers).\n* Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies.\n* Any solid organ transplant within 6 months of randomization.\n* Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 months\n* Life expectancy \\\u003C=6 months.","89 Years",{"count":210,"type":22},120,[212],"PHASE2","Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.",[28],"2026-06-17",{"date":139,"type":33},{"date":218,"type":33},"2025-01-15",{"date":220,"type":22},"2029-06-15",{"name":222,"class":71},"University of Minnesota",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":182,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":51,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":201},"100361232","identification-of-fecal-microbiota-biomarkers-of-spondyloarthritis-in-patients-suffering-from-crohns-disease-100361232","NCT03983473","Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.","Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. Identification de Biomarqueurs de SPondylArthrite Chez Les Patients Atteints de Maladie de CROhn présents Dans le MICrobiote fécal.","MICROSPA","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients will be recruited according to 3 groups:\n* Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.\n* Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and \u002F or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and \u002F or New York modified.\n* Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and \u002F or New York criteria with exclusion diagnosis of Crohn's disease.\n* Patient with the ability to give free and express informed consent.\n\nExclusion Criteria:\n\n* History of colonic resection\n* Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation).\n* Ostomy at the time of sampling\n* BMI\\> 30\n* extreme diet\n* unbalanced diabetes\n* Pregnant woman\n* Patient under guardianship, under curatorship or under the protection of justice Contacts\u002FLocations Central Contact",{"count":232,"type":22},240,[53],"The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing",[28,236],"Spondyloarthritis",{"date":238,"type":33},"2026-06-18",{"date":240,"type":33},"2021-11-16",{"date":242,"type":22},"2027-12-16",{"name":200,"class":71},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":51,"phases":253,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":278},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":252,"type":22},300,[254],"PHASE1","This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[257,28,258,259,260,261,262,263,264,265,266,267,268,57],"Autoimmune Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Psoriatic Arthritis","Rheumatoid Arthritis","Sjogren Syndrome","Systemic Lupus Erythematosus","Systemic Scleroderma","2026-06-16",{"date":215,"type":33},{"date":272,"type":33},"2019-07-16",{"date":274,"type":22},"2028-03-30",{"name":276,"class":277},"National Cancer Institute (NCI)","NIH",52,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":51,"phases":289,"briefSummary":290,"conditions":291,"keywords":294,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":41},"100461857","intestinal-organoids-100461857","NCT05294107","Intestinal Organoids","BIOÏDES","Inclusion Criteria:\n\n* Subjects aged 18 to 75 years\n* Subject undergoing endoscopy as part of the standard of care with the need to take digestive biopsy samples\n* Subject having signed a free and informed consent in writing\n\nExclusion Criteria:\n\n* Subjects under legal protection (safeguard of justice, curatorship or guardianship) or deprived of liberty.\n* Anticoagulant treatment and anti-platelet treatment (except for aspirin 75 mg)","75 Years",{"count":288,"type":22},90,[53],"Over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. Indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). They also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. Finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. The use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.",[292,293,28],"Digestive System Diseases","Inflammatory Bowel Disease, Ulcerative Colitis Type",[295,296,297,298],"biobank","organoids","digestive disease","inflammatory bowel disease","2026-06-15",{"date":215,"type":33},{"date":302,"type":33},"2022-09-06",{"date":304,"type":22},"2028-03-07",{"name":306,"class":71},"Rennes University Hospital",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":314,"minAge":19,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":51,"phases":317,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":328,"locationsCount":41},"100642162","phase-4-a-study-to-assess-concentration-of-tremfya-in-breast-milk-of-lactating-women-who-are-receiving-tremfya-therapeutically-100642162","NCT07654751","A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","CNTO1959ISD4001: A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","Inclusion criteria:\n\n* Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \\[PsA\\], UC and CD) as confirmed by medical records\n* Be medically stable on the basis of medical history review performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator\n* Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1\n* Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study\n* Must be at least 5 weeks postpartum on Day 1\n* Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula\u002Fday) when enrolled in the study\n* Must plan to continue breastfeeding throughout the duration of the study\n\nExclusion criteria\n\n* Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments\n* Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening\n* Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study\n* Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \\[COVID-19\\]) by local health authorities are allowed\n* Has a positive urine pregnancy test on Day 1","FEMALE",{"count":316,"type":22},10,[318],"PHASE4","The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.",[263,321,28,322],"Colitis, Ulcerative","Arthritis, Psoriatic","2026-06-12",{"date":215,"type":33},{"date":299,"type":22},{"date":327,"type":22},"2027-08-31",{"name":39,"class":40},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":337,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":51,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":348,"leadSponsor":350,"locationsCount":41},"100641990","navicam-patency-capsule-to-verify-gastrointestinal-patency-100641990","NCT07649720","NaviCam Patency Capsule to Verify Gastrointestinal Patency","A Prospective, Single Center Clinical Trial Assessing the Efficacy and Safety of the NaviCam Patency Capsule to Verify Gastrointestinal Patency","PATENCY","Inclusion Criteria:\n\n* Patients with suspected or known intestinal stricture (with medical history records, physical examination records, and imaging evidence within the last 6 months.\n* Patients suffering from Crohn's Disease\n* Patients with long-term use of non-steroidal anti-inflammatory drugs.\n* Patients with abdominal symptoms related to intestinal stricture.\n* Patients with chronic inflammatory diseases.\n* Patients with difficulty with balloon-assisted endoscopy (BAE).\n* Patients with a history of small bowel obstruction.\n* Patients with a history of intestinal resection surgery.\n\nExclusion Criteria:\n\n* Patients with esophageal obstruction or swallowing disorder diseases.\n* Patients who are ineligible for surgery or refuse to undergo any abdominal surgery.\n* Patients with known allergies or other contraindications or intolerance to the medications used in this study.\n* Patients with pacemakers or other implanted electronic devices such as cochlear implants, magnetic metal drug infusion pumps, neurostimulators.\n* Pregnant women\n* Patients currently enrolled in another drug or device clinical trial.\n* Other conditions deemed unsuitable for inclusion by the investigator.","22 Years",{"count":7,"type":22},[53],"Participants included in this study will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm weather the capsule is still in the body.",[342,28,343,344],"Intestinal Stricture","NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy","Abdominal Pain","2026-06-10",{"date":269,"type":33},{"date":299,"type":22},{"date":349,"type":22},"2027-03-15",{"name":351,"class":40},"AnX Robotica Corp.",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":41},"100633863","a-study-to-assess-real-world-outcomes-for-long-term-use-of-guselkumab-100633863","NCT07532213","A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab","Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes","LUNAR","Inclusion Criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)\n* Must have confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records\n* Must sign a participation agreement\u002FInformed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":361,"type":22},50,"The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[260,321,28],{"date":323,"type":33},{"date":366,"type":33},"2026-04-13",{"date":368,"type":22},"2029-04-10",{"name":370,"class":40},"Janssen-Cilag A.G., Switzerland",{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":182,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":41},"100554110","decoding-the-clinical-impact-of-host-and-microbial-intestinal-proteomic-landscape-in-crohns-disease-100554110","NCT06494826","Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease","Inclusion criteria - CD study group:\n\n* Age ≥ 18\n* Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.\n* Naïve to any medical or nutritional intervention.\n\nInclusion criteria - healthy controls:\n\n• Age- and gender-matched patients to the CD group, admitted for non-specific GI complaints (such as changes in bowel movements, bloating, abdominal pain) or routine screening for colorectal cancer as part of primary prevention per clinical guidelines.\n\nExclusion Criteria - both groups:\n\n* Established diagnosis of inflammatory bowel disease (IBD) with prior treatment.\n* Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).\n* Type 1 or type 2 diabetes mellitus.\n* Past or present history of malignancy.\n* BMI \\> 30 (kg\u002Fm2)\n* Use of systemic antibiotics or probiotics 2 months prior to enrolment.\n* Use of steroids 2 months prior to enrolment (not including a short course of topical steroidal therapy).\n* Any previous major gastric or intestinal surgery.\n* Suspected or proven extensive involvement of non-ileal small intestine or colon, or significant perianal disease.\n* Significantly stricturing or penetrating (fistulizing) disease at presentation.\n* Chronic treatment with any oral\u002Fsystemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalers\u002Fcreams\u002Fointments should not be excluded from the study.\n* Primary immunodeficiency.\n* Pregnancy or breastfeeding in the last 6 months.\n* Serious medical conditions that may alter the gut microbiome composition, based on investigators judgement (for example primary immunodeficiency, autoimmune disorder, or rheumatologic disease).",{"count":50,"type":22},"In this study, the investigators will explore our protein-based platform assessing commensals potentially contributing to features of CD, while assessing the global composition and abundance of AMPs expressed in the GI tract under specific CD-relevant clinical contexts. This would enable us to (a) identify new commensals contributing to features of CD spectrum and various sub-types; (b) uncover the mechanistic basis of dysbiosis in CD (c) utilize the pipeline to develop new theranostic for disease exacerbation, complication and treatment responses; and (d) potentially enable future exploitation of novel AMP combinations, and their respective antimicrobial capacity to counteract dysbiosis in CD.\n\nUncovering the proteomic manifestations of perturbed host-microbiome communications in CD will eventually enable the development and validation of clinical non-invasive surrogate markers, mechanistically determine causative drivers of CD, and potentially facilitate the development of novel therapeutic interventions.",[28],"2026-06-09",{"date":382,"type":33},"2026-06-11",{"date":384,"type":33},"2024-05-01",{"date":386,"type":22},"2029-05",{"name":388,"class":71},"Weizmann Institute of Science",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":51,"phases":399,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":411},"100643826","phase-3-a-study-of-jnj-78934804-in-participants-with-moderately-to-severely-active-crohns-disease-100643826","NCT07577843","A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","DUET ENCORE-CD","Inclusion criteria:\n\n* Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \\>= 220 but less than or equal to (\\\u003C=) 450 and either: a. Mean daily stool frequency (SF) count \\>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \\>= 2.0, based on the unweighted CDAI component of abdominal pain (AP)\n* Have moderately to severely active ileal and\u002For colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria\n* Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies\n\nExclusion criteria:\n\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC\n* Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study\n* Presence of draining (that is, functioning) stoma or ostomy\n* Has a history of short bowel syndrome, is missing greater than (\\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention\n* Currently has or is suspected of having an abscess",{"count":398,"type":22},460,[400],"PHASE3","The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \\[worsens with time\\] and life-threatening disease of the intestine).",[28],"2026-06-04",{"date":405,"type":33},"2026-06-08",{"date":407,"type":33},"2026-05-22",{"date":409,"type":22},"2030-07-12",{"name":39,"class":40},5,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":427,"leadSponsor":428,"locationsCount":4},"100638573","a-study-of-guselkumab-in-participants-with-crohns-disease-and-ulcerative-colitis-100638573","NCT07606339","A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis","Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis","G-FORCE","Inclusion criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration\n* Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records\n* Must sign a participation agreement\u002Finformed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":421,"type":22},35,"The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.",[28,321],{"date":425,"type":33},"2026-06-05",{"date":299,"type":22},{"date":220,"type":22},{"name":429,"class":40},"Janssen-Cilag Pharma GmbH",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":51,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100631327","phase-3-a-study-of-guselkumab-versus-risankizumab-in-participants-with-moderately-to-severely-active-crohns-disease-100631327","NCT07499232","A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease","A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease","CHARGE","Inclusion criteria:\n\n* Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and\u002For endoscopy\n* Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220 but less than or equal to (\\\u003C=) 450\n* Baseline endoscopic evidence of active ileal and\u002For colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \\>= 4 (for participants with isolated ileal disease) or \\>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:\n\n  1. a minimum score of 1 for the component of \"size of ulcers\" AND\n  2. a minimum score of 1 for the component of \"ulcerated surface\"\n* In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study\n* Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol\n\nExclusion criteria\n\n* Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab\n* Currently has or is suspected to have an abscess\n* Has an active fistula during screening or at Week 0 with an anticipated need for surgery\n* Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention\n* Currently has a malignancy or has a history of malignancy within 5 years before screening",{"count":439,"type":22},530,[400],"The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).",[28],{"date":425,"type":33},{"date":445,"type":33},"2026-04-21",{"date":447,"type":22},"2030-12-11",{"name":39,"class":40},30,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":51,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":411},"100616783","phase-4-a-study-to-evaluate-the-efficacy-of-guselkumab-in-chinese-participants-with-crohns-disease-cd-100616783","NCT07310095","A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)","Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab","Inclusion Criteria:\n\n* Has a confirmed diagnosis of Crohn's disease (CD)\n* Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220 and either mean daily stool frequency (SF) count \\>= 4 or mean daily abdominal pain (AP) score \\>=2\n* Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram \\[mg\\]\u002Fkilogram \\[kg\\] intravenous \\[IV\\] followed by 90 mg subcutaneous \\[SC\\] at week 8) as the instruction manual\n* Initially responded to UST induction therapy and then lose response to UST\n* During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic\n\nExclusion Criteria:\n\n* Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)\n* Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months\n* Is currently enrolled in an interventional clinical study\n* Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome\n* Have a current or be suspected to have an abscess",{"count":458,"type":22},78,[318],"The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.",[28],{"date":425,"type":33},{"date":464,"type":33},"2025-12-30",{"date":466,"type":22},"2027-11-15",{"name":468,"class":40},"Xian-Janssen Pharmaceutical Ltd.",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":51,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":488},"100608066","phase-2-a-study-of-icotrokinra-in-participants-with-moderately-to-severely-active-crohns-disease-100608066","NCT07196722","A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease","A Phase 2b\u002F3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease","ICONIC-CD","Inclusion Criteria:\n\n* Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \\>=220 but \\\u003C=450 and either mean daily SF count \\>=4, or mean daily AP score \\>=2\n* Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and\u002For colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \\>= 6 for participants with colonic or ileocolonic disease, and SES-CD \\>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments\n* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests\n* Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \\[ADT\\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and\u002For advanced oral agents for the treatment of CD- (ADT-inadequate responder \\[IR\\]) as defined in the protocol\n\nExclusion criteria:\n\n* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and\u002For could impair the use of instruments (such as CDAI) to assess response to study intervention\n* Presence of a stoma or ostomy\n* Participants with presence of active fistulas may be included if there is no surgery needed\n* Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline\n* Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization",{"count":478,"type":22},1092,[212,400],"The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).",[28],{"date":425,"type":33},{"date":484,"type":33},"2025-10-03",{"date":486,"type":22},"2032-10-06",{"name":39,"class":40},363,{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":51,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":506,"locationsCount":508},"100630086","phase-2-a-study-of-ly4395089-and-mirikizumab-ly3074828-given-together-and-mirikizumab-alone-in-adults-with-crohns-disease-100630086","NCT07483099","A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease","A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089\u002FMirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease","Inclusion Criteria:\n\nParticipants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:\n\n* Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1\u002Fglucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1\u002Fglucagon (Gcg) RAs, GLP-1\u002FGIP\u002FGcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:\n\n* Must not have a hepatic disease\n* Must not have a history of any other bone disease that affects bone metabolism\n* Must not have had any of the following within the past 180 days before screening:\n\n  * acute myocardial infarction\n  * cerebrovascular incident\n  * hospitalization for unstable angina\n  * hospitalization due to congestive heart failure, or\n  * coronary revascularization\n* Must not have received or will need any other prohibited medications as specified in the protocol","80 Years",{"count":184,"type":22},[212],"The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.",[28],"2026-06-03",{"date":403,"type":33},{"date":504,"type":33},"2026-05-04",{"date":68,"type":22},{"name":507,"class":40},"Eli Lilly and Company",72,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":496,"enrollmentInfo":516,"targetDuration":4,"studyType":51,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":522,"leadSponsor":523,"locationsCount":508},"100630084","phase-2-a-master-protocol-iibd-a-study-of-multiple-drugs-in-adults-with-ulcerative-colitis-or-crohns-disease-100630084","NCT07483073","A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.\n* For UC:\n\n  * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.\n* For CD:\n\n  * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization\n* Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD\n* Have screening laboratory test results within the protocol specified parameters.\n\nExclusion Criteria:\n\n* Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis\n\n  * For UC - must not have a current diagnosis of CD\n  * For CD - must not have a current diagnosis of UC\n* Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol\n* Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome\n* Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data\n* Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action\n* Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment\n* Must not have received or will need any prohibited medications for UC or CD as specified in the protocol",{"count":184,"type":22},[212],"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.",[321,28],{"date":403,"type":33},{"date":504,"type":33},{"date":68,"type":22},{"name":507,"class":40},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":51,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":201},"100592786","phase-4-open-label-single-arm-study-to-assess-the-efficacy-of-mirikizumab-in-patients-with-inflammatory-strictures-due-to-cd-100592786","NCT06997965","Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD","An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease","MIRIAD","Inclusion Criteria:\n\n1. Nonpregnant, nonlactating adults, ≥ 18 years of age.\n2. Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening.\n3. Presence of at least 1 inflammatory stricture in the terminal ileum\\* within reach of an endoscope (passable or nonpassable). Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria:\n\n   * Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); AND\n   * Bowel wall thickening (≥ 25% relative to adjacent bowel; AND\n   * Either prestenotic dilation (defined as a luminal diameter ≥ 3 cm) or nonpassable with adult colonoscope \\*Note: The terminal ileum is defined as the last 15 cm of ileum proximal to the ileocecal valve or ileocolonic anastomosis. Other small bowel strictures will be considered on a case-by-case basis following discussion with the sponsor. Two strictures within 3 cm are considered the same stricture, and a long segment with multiple areas of narrowing or multiple strictures, that have inflammation between them, is counted as 1 stricture.\n4. Abdominal pain after eating and\u002For limitations in the amount\u002Ftypes of food eaten.\n5. Presence of tolerable obstructive symptoms and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study period. Participants should have sufficient food intake, even with diet modification, defined as a stable weight over 4 weeks prior to initiation of study intervention.\n6. Participants taking oral corticosteroids (eg, ≤ 20 mg\u002Fday prednisone or ≤ 9 mg\u002Fday budesonide) for ≥ 4 weeks prior to screening. Participants must be willing to undergo corticosteroid taper 8 weeks after initiation of study intervention as per standard of care.\n7. Participants can be on stable background therapy for CD and must agree to maintain the background therapy during the study. Acceptable stable background therapies include:\n\n   * Oral 5-ASA drugs or sulfasalazine ≤ 4.8 g per day, for ≥ 4 weeks prior to screening\n   * AZA, 6-MP, or MTX for ≥ 4 weeks prior to Screening\n   * Any rectal therapy for treatment of CD for ≥ 4 weeks prior to screening\n   * Antidiarrheal drugs for ≥ 8 weeks prior to screening\n   * Bile acid sequestrants for ≥ 4 weeks prior to screening\n8. Contraceptive use by study participants should be in accordance with the mirikizumab product monograph and local guidelines.\n9. Signed informed consent.\n\nExclusion Criteria:\n\n1. History or current diagnosis of UC, indeterminate colitis, ischemic colitis, nonsteroidal anti inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.\n2. CD-related complications:\n\n   * Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.\n   * Short bowel syndrome.\n   * Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.\n   * Inactive fistulae in or adjacent to an ileal stricture. Participants with perianal fistulae could be included provided there is no evidence of peri-anal abscess \\> 2 cm.\n   * Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated.\n   * Abscess located \\\u003C 2 cm in relation to the stricture.\n   * Toxic megacolon.\n3. Any major surgery, in the investigator's opinion, performed within 8 weeks prior to screening or planned during the study (ie, any surgical procedure requiring general anesthesia).\n4. Malignancies or history of malignancy within 5 years of the initial screening visit, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n5. Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury.\n6. Liver chemistry parameters that exceed the following thresholds:\n\n   * ALT or AST \\> 2 × ULN\n   * Alkaline phosphatase \\> 2.5 × ULN\n   * Total bilirubin \\> 1.5 × ULN\n7. Concomitant use of the following medications during the screening period or throughout the study:\n\n   * Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening.\n   * Biologics (anti-tumor necrosis factor, anti-integrins, ustekinumab, or risankizumab) within 8 weeks prior to screening.\n   * JAK inhibitor within 4 weeks prior to screening and throughout the study.\n   * IL23p19 inhibitor within 4 weeks (or 5 half-lives, whichever is longer) prior to screening, or a history of nonresponse or intolerance to IL23p19 inhibitors.\n8. Not up-to-date with current age-appropriate vaccinations in accordance with current immunization guidelines and the investigator's usual standard of care at screening.\n9. Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening.\n10. Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies.\n11. Systemic or opportunistic infections including:\n\n    * HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to Day 0, retesting is not required.\n    * Known active or latent TB; if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before Day 0.\n    * Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin).\n    * Active CMV infection, as per investigator judgement\n    * Other systemic or opportunistic infection, any other clinically significant extraintestinal infection, infection that is not responding to standard treatment, or recurring infection within 6 months of Day 1.\n12. Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients.\n13. Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic.\n14. Prior enrolment in the current study and had received study treatment.\n15. Any acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study intervention administration, or may interfere with the interpretation of study results, as determined by the investigator.\n16. Unwillingness to withhold protocol-prohibited medications during the trial.",{"count":184,"type":22},[318],"This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.",[28],"2026-05-28",{"date":538,"type":33},"2026-06-01",{"date":540,"type":33},"2026-04-20",{"date":542,"type":22},"2028-04-01",{"name":544,"class":71},"Alimentiv Inc.",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":552,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":51,"phases":556,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":576},"100499276","phase-4-clinical-imaging-and-endoscopic-outcomes-of-children-newly-diagnosed-with-crohns-disease-100499276","NCT05781152","Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease","CAMEO","Phase 1 Inclusion Criteria\n\n1. Age ≥ 6 years and \\\u003C 18 years at enrollment\n2. Suspected diagnosis of CD\n3. Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patients presenting with diarrhea. If history of C. difficile then a minimum of 6 weeks duration from treatment start and negative repeat stool for C. difficile toxin.\n4. Parent\u002Fguardian consent and patient assent\n5. Ability to remain in follow-up for up to 6 months of initial observation followed by a minimum of 52 weeks after possible start of anti-TNF therapy\n\nPhase 1 Exclusion Criteria\n\n1. Diagnosis of CD following abdominal resectional surgery\u002Fappendectomy at initial presentation\n2. Investigator judgment that patient has high likelihood (\\>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with perforation, bowel obstruction from stricture)\n3. Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)\n4. Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling\n5. Pregnancy\n6. Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)\n7. Previous treatment with immunomodulators within one year of enrollment or anti-TNF therapy within two years of enrollment for other medical conditions (e.g., juvenile idiopathic arthritis)\n8. Previous treatment with non-anti TNF biologics or small molecules for non-IBD indications in the past 6 months, with the exception of dupilumab (Dupixent) for asthma, eczema, or eosinophilic esophagitis\n9. Inability to have MRE because of claustrophobia or other reasons\n\nPhase 2 Inclusion Criteria\n\n1. Met all eligibility criteria for Phase 1 and participated in Phase 1\n2. Diagnosed with macroscopic CD involving the terminal ileum and\u002For colon by endoscopic evaluation and\u002For MRE\n3. MRE imaging within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy (TT). A limited 'research protocol' MRE is acceptable in participants who have undergone a clinical CTE during their initial diagnostic evaluation; see Manual of Procedures for details.\n4. Received at least one of the following as initial therapy upon diagnosis:\n\n   1. Corticosteroids\n   2. Immunomodulator\n   3. Aminosalicylic acids (5-ASA)\n   4. Defined nutritional therapy\n   5. Anti-TNF (adalimumab or infliximab)\n5. Commenced adalimumab or infliximab anti-TNF therapy guided by ROADMAB™ CDST as first therapy or within 180 days of diagnosis (TD), with or without concomitant immunomodulator\n\n6 a. Had ileal and rectal biopsies, OR b. Ileal biopsies are not obtained secondary to inflammatory or structural changes at the ileocecal valve or distal ileum that prevent ileal intubation. To be acceptable for Phase 2, the following additional criteria must be met: b1. Gross inflammation or obvious narrowing at the IC valve or distal ileum as documented by the video colonoscopy, AND b2. MRE documentation of TI inflammation with or without narrowing, OR c. Ileal biopsies are not obtained secondary to inflammatory or structural changes due to colonic CD.\n\n7\\. Parent\u002Fguardian consent and patient assent 8. Ability to remain in follow-up for a minimum of 52 weeks after start of anti-TNF therapy\n\nPhase 2 Exclusion Criteria\n\n1. Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy and normal MRE\n2. Orofacial CD only\n3. Esophageal, gastric, duodenal, and\u002For jejunal CD only\n4. Severe complex fistulizing perianal disease +\u002F- abscess, or perianal disease requiring surgical intervention or likely to require on-going surgical intervention possibly including diversion. The placement of a seton is not exclusionary. Incision and drainage of a perirectal abscess is also not exclusionary.\n5. Perianal CD only with no evidence of luminal disease\n6. Internal fistulizing disease at diagnosis\n7. Initial IBD treatment with non-anti-TNF biologic or small molecule therapy\n8. Received any anti-TNF agent other than adalimumab or infliximab\n9. Investigator judgment that patient unlikely to return for clinical, endoscopic or MRE follow-up\n10. Inability to have MRE because of claustrophobia or other reasons\n11. Video of baseline endoscopy not available for central reading, unless otherwise approved by the Clinical Coordinating Center (Adequate photo documentation required)\n12. Underwent bowel resection within 3 months of diagnosis (TD)","6 Years","17 Years",{"count":555,"type":22},900,[318],"Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps\u002Fpain, diarrhea, blood in the stool, weight loss, or delayed growth in children. While the exact cause of CD is not certain it is thought that the immune system located in the intestine reacts abnormally to the large number of bacteria contained there. The investigators think that diet, exposure to antibiotics early in life, and having a family history of CD puts people at increased risk for developing CD. In order to decrease the inflammation doctors use what is called biologic therapy with anti-TNF molecules that can be given through an intravenous or shots. TNF is a chemical made by white blood cells that is involved in inflammation. When this type of treatment is given early after diagnosis it is more effective than when it is given later. The investigators have learned that it is important to give the optimum (ideal) amount of this medicine guided by certain blood tests. The investigators also know that not everyone responds to this therapy but do not understand the reasons for this variability between people. The CAMEO study has been started to help understand what factors are important in determining whether a child with CD completely heals the inflammation after anti-TNF therapy. The investigators will do that by measuring certain markers of inflammation in the blood and stool and by looking at a person's genes (DNA) and how inflammation is controlled in the intestine. These inflammation tests will be done before, during, and after one year of anti-TNF therapy. The investigators will determine how much healing has taken place by comparing the results of the colonoscopy and a special type of MRI that are both done before anti-TNF and then again one year later. The goal in treating CD is to heal both the lining and the wall of the intestine. Children ages 6-17 years who are thought to have CD and are about to undergo their diagnostic colonoscopy are eligible to be enrolled. If they are found to indeed have CD and start an anti-TNF medicine within 6 months they can continue in the study. There are no increased risks of participating in this study beyond those normally associated with having CD and its treatment. By better understanding why the bowel does or does not heal, doctors will be better able to provide personalized care.",[28],[560,561,562,563,564,565,298,566,567],"crohn disease","children","pediatric","anti-TNF therapy","therapeutic drug monitoring","intestinal microbiome","gene expression","genomic DNA",{"date":569,"type":33},"2026-05-27",{"date":571,"type":33},"2023-06-10",{"date":573,"type":22},"2029-07-01",{"name":575,"class":71},"Connecticut Children's Medical Center",26,{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":41},"100420181","testing-of-an-educational-tool-for-patients-with-melanoma-and-pre-existing-autoimmune-disease-who-are-candidates-for-immune-checkpoint-inhibitors-100420181","NCT04751396","Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors","Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers","Inclusion Criteria:\n\n* Diagnosis of melanoma\n* Diagnosis of pre-existing autoimmune disease\n\n  * Inflammatory bowel disease\n\n    * Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist\n    * For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically\n    * Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists)\n  * Rheumatoid arthritis\n\n    * Diagnosis of rheumatoid arthritis by a rheumatologist\n    * Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy\n  * Systemic lupus erythematosus\n\n    * Diagnosis of systemic lupus erythematosus by a rheumatologist\n  * Psoriasis\n\n    * Diagnosis of psoriasis by a dermatologist\n    * Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies\n  * Spondyloarthropathies\n\n    * Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis\u002Fspondylitis by a rheumatologist\n    * Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy\n* Age of 18 years or older\n* Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor\n* E-mail access and computer with Internet access or telephone\n* Ability to communicate in English or Spanish\n* CLINICIAN\n* Prescribed immune checkpoint inhibitors\n* Are providing care for patients with melanoma\n* In the clinics at MD Anderson",{"count":585,"type":22},125,"This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.",[588,257,28,589,590,260,591,263,264,592,265,267,57],"Ankylosing Spondylitis","Enteropathic Arthritis","Enteropathic Spondylitis","Melanoma","Reactive Arthritis","2026-05-18",{"date":595,"type":33},"2026-05-20",{"date":597,"type":33},"2022-04-20",{"date":599,"type":22},"2027-02-02",{"name":601,"class":71},"M.D. Anderson Cancer Center"]