[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-bowel-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-bowel-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,129,0,25,[9,48,75,107,138,168,189,210,232,259,278,306,329,349,371,394,418,436,459,492,512,562,583,607,626],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100628048","developing-a-self-management-intervention-to-improve-health-outcomes-for-patients-with-inflammatory-bowel-disease-100628048",false,"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","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29],"Inflammatory Bowel Diseases","Ulcerative Colitis","Crohn Disease",[31,32,33,34],"Digital self-management program","Standard of care","Randomization","Questionnaires","NOT_YET_RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":21},"2026-07",{"date":43,"type":21},"2028-03",{"name":45,"class":46},"University of Michigan","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":74},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":57,"type":21},645,[59],"PHASE2","This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[28,27,62,63],"Colitis","Colitis, Ulcerative","RECRUITING","2026-06-26",{"date":67,"type":39},"2026-06-29",{"date":69,"type":39},"2025-05-27",{"date":43,"type":21},{"name":72,"class":73},"Spyre Therapeutics, Inc.","INDUSTRY",243,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":47},"100644630","resting-energy-expenditure-in-pediatric-patients-with-inflammatory-bowel-disease-ree-mici-100644630","NCT07670975","Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)","Measurement of Basal Metabolism in Patients With Crohn's Disease and Ulcerative Colitis and Correlation With Disease Activity.","REE-MICI","Inclusion Criteria:\n\n* Pediatric patients aged 6 to 17 years\n* New diagnosis of inflammatory bowel disease, including Crohn disease or ulcerative colitis, according to ECCO\u002FESPGHAN criteria\n* Written informed consent signed by parents or legal guardians\n\nExclusion Criteria:\n\n* Intestinal surgery within 6 weeks before the first evaluation\n* Parenteral or enteral nutrition within 6 weeks before the first evaluation\n* Eating disorders or other chronic diseases associated with possible malabsorption","6 Years","17 Years",{"count":86,"type":21},50,"OBSERVATIONAL","This multicenter prospective observational non-pharmacological study aims to evaluate resting energy expenditure (REE) in pediatric patients affected by inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. REE will be measured using indirect calorimetry and estimated using predictive equations. The study also aims to investigate the relationship between REE, disease activity, and dietary or pharmacological treatments. Clinical, laboratory, anthropometric, nutritional, and disease activity data will be collected during routine clinical follow-up at diagnosis, after induction therapy, and during follow-up visits.",[90,63,27],"Crohn Disease Colitis",[92,93,94,95,96,97,98],"Energy Metabolism","Calorimetry, Indirect","Malnutrition","Pediatric Obesity","Nutritional Status","Child","Disease Activity","2026-06-22",{"date":65,"type":39},{"date":102,"type":39},"2025-05-01",{"date":104,"type":21},"2027-11",{"name":106,"class":46},"Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100533520","phase-2-a-phase-2-study-to-evaluate-morf-057-in-adults-with-moderately-to-severely-active-crohns-disease-100533520","NCT06226883","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","GARNET","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease","85 Years",{"count":117,"type":21},385,[59],"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).",[27,121],"Crohn's Disease",[123,124,125,126,127,113],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin","2026-06-19",{"date":130,"type":39},"2026-06-23",{"date":132,"type":39},"2024-07-18",{"date":134,"type":21},"2030-06",{"name":136,"class":73},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",226,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100427330","phase-3-a-master-protocol-amaz-a-study-of-mirikizumab-ly3074828-in-pediatric-participants-with-ulcerative-colitis-or-crohns-disease-shine-on-100427330","NCT04844606","A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)","A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease","SHINE-ON","Inclusion Criteria:\n\n* Participants from originating studies (I6T-MC-AMBA \\[NCT05784246\\], I6T-MC-AMBU \\[NCT04004611\\], I6T-MC-AMAM \\[NCT03926130\\]) , I6T-MC-AMAY \\[NCT05509777\\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab\n* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.\n* Female participants must agree to contraception requirements.\n\nExclusion Criteria:\n\n* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.\n* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.\n* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.\n* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.\n* Participants must not have adenomatous polyps that have not been removed.\n* Participants must not be pregnant or breastfeeding.","2 Years","19 Years",{"count":149,"type":21},150,[151],"PHASE3","The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.",[28,154,27,121],"Ulcerative Colitis Chronic",[156,157,158,159],"Pediatric Ulcerative Colitis","Pediatric Crohn's Disease","Pediatric UC","Pediatric CD",{"date":130,"type":39},{"date":162,"type":39},"2021-05-26",{"date":164,"type":21},"2030-12",{"name":166,"class":73},"Eli Lilly and Company",68,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":175,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":47},"100555300","digital-mind-body-intervention-among-black-and-hispanic-patients-living-with-inflammatory-bowel-disease-100555300","NCT06510296","Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease","DMBI","Inclusion Criteria:\n\n* age ≥ 18 years\n* self-identify as Black\u002FAfrican American and\u002For Hispanic\u002FLatino(a\u002Fx)\n* diagnosed with Crohn's disease or ulcerative colitis\n* ability to provide informed consent in English\n* elevated psychological distress: at least one T-score within 2.5 standard deviations above the mean -- NIH Toolbox Perceived Stress Scale or in the domains of either Anxiety or Depression on the NIH PROMIS-29.\n\nExclusion Criteria:\n\n* Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.\n* Current suicidality, past suicide attempt, or psychiatric hospitalization.",true,{"count":20,"type":21},[24],"The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased IBD activity (i.e., gut-brain interaction). Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life (HRQoL). This has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing. The IBD Social Cognitive Model (IBD SCM) posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone. While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD, access and scalability of this form of support is not yet widespread, particularly in resource-limited settings. Though many people with IBD have significant psychological distress, mental health care is underutilized with cost cited as a barrier.\n\nThe emergence of digital interventions in clinical practice presents an opportunity to address access, scalability, and cost barriers. However, current testing of digital interventions to address gut-brain interactions (digital mind-body intervention, DMBI) among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits. Individuals with limited resources and those from racial and ethnic minority groups (e.g. Black, Hispanic) often have socioecological factors, such as healthcare access and mental health stigma, that impede their use of psycho-behavioral resources. DMBI development informed by participatory research approaches are, therefore, critical to facilitate equitable engagement and utilization. Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance, mindfulness, and values-based approaches.\n\nAlthough high quality evidence demonstrates psychological improvement with DMBI in IBD, feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking.",[121,28,27],"2026-06-16",{"date":182,"type":39},"2026-06-17",{"date":184,"type":21},"2027-07",{"date":186,"type":21},"2028-09",{"name":188,"class":46},"Montefiore Medical Center",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100642352","a-multi-center-randomized-controlled-trial-on-the-impact-of-disease-subtype-based-active-video-education-on-bowel-preparation-quality-in-patients-with-inflammatory-bowel-disease-100642352","NCT07582731","A Multi-Center Randomized Controlled Trial on the Impact of Disease Subtype-Based Active Video Education on Bowel Preparation Quality in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n1. Age between 18 and 75 years, inclusive.\n2. Confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's disease (CD) according to standard clinical guidelines.\n3. Scheduled for elective colonoscopy for IBD monitoring or disease activity assessment.\n4. Able to understand written and verbal instructions and to use a smartphone to view video education materials.\n5. Voluntary participation with written informed consent.\n\nExclusion Criteria:\n\n1. Absolute contraindications to colonoscopy, including acute gastrointestinal perforation, fulminant colitis, toxic megacolon, or hemodynamic instability.\n2. History of total or subtotal colectomy.\n3. Acute or chronic intestinal obstruction.\n4. Severe cardiac, pulmonary, hepatic, or renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m², NYHA class III\u002FIV).\n5. Severe psychiatric or cognitive impairment that prevents understanding of the study requirements.\n6. Inability or unwillingness to provide written informed consent.\n7. Pregnant or breastfeeding women.","75 Years",{"count":197,"type":21},600,[24],"This multi-center, prospective, randomized controlled trial evaluates whether disease subtype-based active video education improves bowel preparation quality in patients with inflammatory bowel disease (IBD) undergoing colonoscopy. A total of 600 IBD patients from 13 centers will be randomized 1:1 to standard education plus subtype-specific video education (intervention group) or standard education alone (control group). The primary outcome is the Boston Bowel Preparation Scale (BBPS) score.",[27],"2026-06-13",{"date":180,"type":39},{"date":204,"type":21},"2026-06-01",{"date":206,"type":21},"2027-07-01",{"name":208,"class":46},"Jie Liang",12,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100560017","boom-ibd2-pivotal-clinical-trial-100560017","NCT06571669","BOOM-IBD2 Pivotal Clinical Trial","BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.","Inclusion Criteria:\n\n* Male or female\n* 18 to 85 years of age\n* Diagnosed with ulcerative colitis\n* Ability and willingness to consent to participate by signing the informed consent form\n* Ability to comply with the protocol and willingness to comply with all follow up requirements\n\nExclusion Criteria:\n\n* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study\n* Any psychiatric or personality disorder at the discretion of the study investigator\n* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)\n* Active clostridium difficile infection of the colon\n* Active cytomegalovirus (CMV) infection of the colon\n* Evidence of colonic perforation\n* Fulminant colitis requiring emergency surgery\n* Microscopic, ischemic or infectious colitis\n* Unresected neoplasia of the colon\n* Colonic stricture unable to pass a colonoscope\n* Current evidence of cancer in the gastrointestinal tract\n* Current participation in another clinical trial\n* Previous history of surgery for ulcerative colitis, or probably to require such intervention\n* Previously implanted with a neurostimulation device or participated in a neurostimulation trial\n* Inability to operate the patient programmer",{"count":218,"type":21},137,[24],"Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.",[28,27],"2026-06-12",{"date":224,"type":39},"2026-06-15",{"date":226,"type":39},"2025-01-31",{"date":228,"type":21},"2027-11-30",{"name":230,"class":73},"Boomerang Medical",19,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100632399","phase-2-proof-of-concept-study-evaluating-the-efficacy-and-safety-of-ath-063-treatment-in-patients-with-relapsedrefractory-moderately-to-severely-active-ulcerative-colitis-uc-100632399","NCT07513181","Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed\u002FRefractory Moderately to Severely Active Ulcerative Colitis (UC)","A Phase 2b, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Clinical Study to Evaluate the Efficacy and Safety of ATH-063 Induction Therapy in Patients With Biologic Relapsed\u002FRefractory Moderately to Severely Active Ulcerative Colitis (UC)","Inclusion Criteria:\n\n* Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.\n* Male or female (assigned at birth, inclusive of all gender identities) participants 18 to 75 years of age, inclusive, at the time of informed consent.\n* Male or female participants must be postmenopausal\u002Fsurgically sterile, sexually abstinent, or using 2 forms of protocol-specified contraception, including 1 physical barrier method (condom or diaphragm) plus 1 highly effective method (ie, hormonal contraception., intrauterine device, intrauterine hormone-releasing system, bilateral occlusion, vasectomy, or complete sexual abstinence). Women of childbearing potential (WOCBP) must also be nonpregnant and not breastfeeding.\n* Has a diagnosis of UC confirmed by endoscopic and histologic evidence at least 4 months before screening. If confirmation is not available in source documentation, the screening endoscopy and histology reports for this trial may serve as evidence.\n* Has moderately to severely active UC, defined as a UCDSS of 5 to 9, with an EMA subscore of 2 to 3 (obtained during the central review of the screening video endoscopy).\n* Has active UC that extends \\>15 cm beyond the anal verge, as identified at the screening colonoscopy.\n* Has documentation of moderately to severely active UC that is refractory (inadequate response - signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing indicated in the product label; or loss of response - recurrence of signs and symptoms of active disease during maintenance dosing following prior clinical benefit \\[discontinuation despite clinical benefit does not qualify as having failed biologic therapy\\]) to 1 to 2 prior approved biologic\u002Fadvanced UC therapies (ie, biologic therapies, such as antitumor necrosis factor \\[TNF\\], anti-integrin, and anti-interleukin \\[IL\\]-12\u002F23 therapies; or advanced therapies, such as sphingosine 1-phosphate \\[S1P\\] receptor modulators and Janus kinase \\[JAK\\] inhibitors \\[eg, tofacitinib\\]; one of which must have been an anti-TNF therapy; the other, if applicable, may have had the same or a different mechanism of action) when given at doses approved for the treatment of UC.\n* Has documentation of an inadequate response, loss of response, or intolerance to conventional standard-of-care therapy with corticosteroids (ie, prednisone and budesonide), 5-ASAs (ie, mesalamine, sulfasalazine), or other immunomodulators (ie, thiopurines, methotrexate, cyclosporine, and tacrolimus).\n* Any prior therapy, including any investigational drug, not permitted as concomitant standard-of-care therapy must have been discontinued for at least 4 weeks or 5 half-lives prior to screening, whichever is longer, or the participant must have no active drug detected at the start of screening, as determined by therapeutic drug monitoring.\n* Has screening laboratory test results within the following parameters:\n\n  1. Hemoglobin ≥8 g\u002FdL\n  2. White blood cell (WBC) ≥3×103\u002FμL\n  3. Neutrophil count ≥1.5×103\u002FμL\n  4. Platelet count ≥100,000\u002FμL\n  5. Serum creatinine ≤1.5 mg\u002FdL and\u002For creatinine clearance \\>80 mL\u002Fmin\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values must be within 2× the upper limit of normal (ULN) for the laboratory conducting the test\n  7. Total bilirubin ≤1.5×ULN at screening in participants who do not have Gilbert's syndrome\n  8. Total bilirubin ≤2×ULN at screening in participants with Gilbert's syndrome\n\nExclusion Criteria:\n\n* Clinically significant abnormal medical history, or abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening, that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.\n* Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of oral medicines (as judged by the investigator).\n* Hospitalization for exacerbation of UC requiring intravenous (IV) corticosteroids (ie, UC flare) within 12 weeks prior to screening.\n* Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation.\n* Investigator judgment that the participant is likely to require a colectomy within 12 weeks of the start of trial medication administration.\n* Has UC that is limited to the rectum or right colon.\n* Presence or history of an enteric fistula consistent with Crohn's disease (CD).\n* History of ischemic colitis.\n* History of indeterminate colitis or microscopic colitis.\n* History of radiation colitis.\n* History of CD.\n* History of colonic stricture.\n* Positive stool test result for Clostridioides difficile (C. difficile), bacterial infection, or ova and parasites at screening (for bacterial infections, only exclusionary if the active infection requires antibiotic treatment).\n* History or evidence of any extensive colonic resection or subtotal or total colectomy (with or without presence of a stoma or ileoanal pouch) that would prevent adequate evaluation of trial intervention on clinical disease activity, as per the investigator's judgment.\n* Current colonic adenomas, dysplasia, or past confirmed colonic dysplasia that has not been eradicated (participants who have had UC \\>8 years should have had a colonoscopy to screen for dysplasia within 1 year prior to the screening visit, or this can be performed as part of the screening colonoscopy). A participant with prior history of adenomatous polyps will be eligible if the polyps have been completely removed (documented), and the participant is free of polyps and does not have evidence of dysplasia on histologic evaluation at screening.\n* Any current malignancy judged by the investigator not to be in full remission (except for basal cell and in situ squamous cell carcinomas of the skin that have been fully excised and resolved). Prior malignancy must have been in remission for \\>2 years prior to screening.\n* Exposure to \\>2 prior approved biologic\u002Fadvanced UC therapies (as defined in Inclusion Criterion) when given at doses approved for the treatment of UC.\n* Use of agents that deplete B or T cells (eg, rituximab) within 12 months of first trial medication administration.\n* Participants with potentially active hepatitis B virus (HBV) infection or at risk of reactivation of HBV infection; hepatitis C virus (HCV) antibody (anti-HCV) or HCV RNA (unless history of HCV that has been cleared and documented with sustained virologic response for \\>2 years); or human immunodeficiency virus antibodies (anti-HIV)1\u002F2 at screening.\n* Has severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease; or signs or symptoms thereof.\n* History of, or concurrent, unstable ischemic heart disease or severe congestive heart failure (New York Heart Association Class III or IV).\n* History of alcohol or drug abuse or dependence within 1 year before screening that, in the opinion of the investigator, would impair the ability of the participant to comply with trial protocol requirements.\n* Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.\n* Receiving tube feeding, defined formula diets, or total parenteral alimentation.\n* History of bleeding disorders or recent use of antiplatelet or antithrombotic agents that in the investigator's judgment preclude safely performing endoscopic procedures and biopsy within the timeframe outlined in the trial protocol.\n* Use of drugs that are inhibitors of P-glycoprotein (P-gp; eg, amiodarone, clarithromycin, cyclosporine, ketoconazole, ritonavir, verapamil) or breast cancer resistance protein (BCRP; eg, Cyclosporin A, tacrolimus, gefitinib).\n* Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety (including any known hypersensitivity to the trial medication products), as per the investigator's judgment.",{"count":240,"type":21},120,[59],"The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic\u002Fadvanced therapy relapsed\u002Frefractory moderately to severely active UC.",[28,27,244],"Autoimmune Diseases",[62,246,247,248],"Ulcerative","IBD","Biologic refractory","2026-06-04",{"date":251,"type":39},"2026-06-08",{"date":253,"type":21},"2026-06",{"date":255,"type":21},"2028-12-14",{"name":257,"class":73},"Athos Therapeutics Inc",2,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":84,"enrollmentInfo":267,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":276,"locationsCount":47},"100632981","a-database-study-of-disease-treatment-patterns-and-healthcare-use-in-children-with-inflammatory-bowel-diseases-in-korea-100632981","NCT07520747","A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea","Epidemiology, Treatment Patterns, and Healthcare Resource Utilization in Pediatric Patients Under 18 Years of Age With Inflammatory Bowel Diseases in Korea: A Claims Database Study","Ped IBD Claims","Inclusion Criteria:\n\n* Participants with at least two outpatient or one inpatient diagnosis codes for the same disease type (either CD or UC) using international classification of diseases, tenth revision (ICD-10) codes (K50. X for CD and K51. X for UC) recorded as primary or the first secondary diagnosis, and the codes for rare and intractable disease registration program (V130 for CD, V131 for UC) during the index period\n* Participants who received at least one prescription for conventional pediatric inflammatory bowel disease (IBD)-related medications (for example, 5-aminosalicylic acids \\[5-ASAs\\], exclusive enteral nutrition \\[EENs\\], corticosteroids, immunomodulators, or biologic drugs) during the index period\n\nExclusion Criteria:\n\n\\- No specific exclusion criteria are defined in this study",{"count":268,"type":21},8000,"The purpose of this study is:\n\n* to find out out the number of children who develop crohn's disease (CD) and ulcerative colitis (UC) each year and are living with the disease and to see how this differs by age groups.\n* to understand how children of different age groups are treated over time and how their treatment changes as they grow.\n* to assess how often children use healthcare services and how much this costs for different age groups over several years.\n\nCD and UC are long-term diseases that cause inflammation in intestine (part of digestive system) and develop ulcers.",[27],{"date":272,"type":39},"2026-06-05",{"date":274,"type":39},"2026-04-07",{"date":67,"type":21},{"name":277,"class":73},"Janssen Korea, Ltd., Korea",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":258},"100623826","phase-1-fecal-microbiota-transplantation-in-an-expanded-ulcerative-colitis-population-100623826","NCT07401680","Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population","A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)","FRONTIER-UC","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Able to provide informed consent\n3. Established UC diagnosis through standard endoscopic and histologic criteria\n4. Active UC\n5. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial\n6. Willing and able to comply with all required study procedures\n\nExclusion Criteria:\n\n1. Severe UC requiring hospitalization\n2. Crohn's disease or indeterminate colitis\n3. Irritable bowel syndrome\n4. Intestinal infection within 4 weeks of enrollment\n5. Evidence of toxic megacolon or gastrointestinal perforation on imaging\n6. Planned colectomy\n7. Abdominal surgery within 60 days of enrollment\n8. Neutropenia with absolute neutrophil count \\\u003C0.5 x 109\u002FL\n9. Peripheral white blood cell count \\> 35.0 x 109\u002FL and fever (\\>38C)\n10. Planned or actively taking another investigational product\n11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse\n12. Severe underlying disease such that the patient is not expected to survive for at least 30 days\n13. Pregnancy or breastfeeding\n14. Unwilling to discontinue non-dietary probiotic\n15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study\n16. FMT for any reason within 6 months of enrollment\n17. Investigator's judgement that enrolment is not in the best interest of the patient",{"count":287,"type":21},85,[289],"PHASE1","This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.",[28,27,292],"Clostridioides Difficile Infection",[294,295,296,297],"Fecal microbiota transplantation","FMT","Lyophilized fecal microbiota transplantation","LFMT","2026-06-02",{"date":249,"type":39},{"date":301,"type":39},"2026-03-01",{"date":303,"type":21},"2028-12-01",{"name":305,"class":46},"University of Alberta",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":315,"studyType":87,"phases":4,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":47},"100438894","mechanism-of-chronic-pain-in-patients-with-ibd-100438894","NCT04995224","Mechanism of Chronic Pain in Patients With IBD","Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease","Inclusion Criteria :\n\n* Males or females who are over 18 years old.\n* Patients who are diagnosed with UC or CD within 6 months before the enrolment.\n* Patients who have access to the internet and have the IT skills to perform basic tasks e.g. operate emails and fill out questionnaires.\n* Patients who are willing and able to participate in the study for the required duration, can understand and are willing to sign the consent forms and agree to undergo all protocol-related tests and procedures.\n\nExclusion Criteria:\n\n* Patients who have severe extensive colitis and are at imminent risk of colectomy.\n* Patients who already have the presence of a stoma or history of a fistula or stricture due to another diagnosis.\n* Patients who are pregnant, lactating or thinking of becoming pregnant during the study period\n* Patients who have unstable acute illness or exacerbation of an unstable chronic illness or chronic disease (other than IBD) that may affect assessments for this study as determined by previous physical examination, medical history, vital signs, ECG, and laboratory (serum biochemistry, hematology, urinalysis) assessments.\n* Patients with a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection that are not in remission and are on medication that can affect gastrointestinal function.\n* Patients who have known or suspected to have a severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF) and chronic arrhythmia such as atrial fibrillation\n* Patients who have known or suspected cerebrovascular disease (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)\n* Patients who have a known history or suspected history of substance abuse or addiction (within the last five years).",{"count":314,"type":21},25600,"18 Months","Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD). Up to 70 % of IBD patients experience pain when the disease is active. Even when patients with IBD are in remission, 20-50 % experience ongoing pain. The precise mechanism of developing chronic abdominal pain in patients with IBD in remission remains unknown.\n\nThe aim of this study is to identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed IBD (ulcerative colitis and Crohn's disease).\n\nThis study consists of 4 sections (Study 1A, 1B, 2, and 3):\n\nStudy 1A: We perform a longitudinal study in 150 patients with new-onset IBD over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain. This is a collaborative study with IBD BioResourse Inception study. We administer online questionnaires, collect stool and blood samples, and record heart rate. Other physiological data collected by the Inception study will be also used for the analysis.\n\nStudy 1B: This is also a collaborative study with the Inception study. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients (n=450) that are included in the Inception study on a voluntary basis. Patients will be followed for 12 months.\n\nStudy 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD. The participants for study 2 are patients registered in IBD BOOST study and those for study 3 are patients registered in IBD BioResource (but not in IBD Boost study). Detailed online questionnaires will be administered to them. These studies are just one-day assessment.",[27],[319],"inflammatory bowel diseases, IBD","2026-05-20",{"date":322,"type":39},"2026-05-22",{"date":324,"type":39},"2021-07-26",{"date":326,"type":21},"2027-09-30",{"name":328,"class":46},"Queen Mary University of London",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":337,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":345,"leadSponsor":347,"locationsCount":47},"100637711","guselkumab-for-overlap-inflammatory-bowel-disease-and-spondyloarthritis-100637711","NCT07602517","Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis","GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis","GLOBE-SpA","Inclusion Criteria:\n\n* Confirmed diagnosis of Crohn's disease or Ulcerative Colitis disease based on confirmatory colonoscopy with biopsies, or if small bowel only, MRE with corresponding history\n* Age between 18 to 75 years old\n* Inflammatory bowel disease unclassified (IBD-U) subjects are eligible for inclusion if based on investigator assessment, the subject meets criteria for IBD-U, defined as chronic inflammatory bowel disease with overlapping features of Crohn's disease or ulcerative colitis\n* Initiating Guselkumab therapy in the next 30 days\n* Bio-naïve or bio-experienced\\* to ≤3 mechanisms of action \\*Defined as prior exposure or failure, as defined by inadequate efficacy or intolerance\n\nExclusion Criteria:\n\n* Unable to provide consent for participation\n* Known SpA diagnosis, prior to screening\n* Has started Guselkumab therapy\n* Prior exposure to IL-23 therapy (like Mirikizumab, Ustekinumab, etc.)\n* Prior exposure to TB, active or currently undergoing treatment for latent TB\n* Pregnancy as some pregnancy symptoms could be mistaken for SpA symptoms\n* Prior exposure to combination advanced biologic therapies",{"count":338,"type":21},75,"This is an observational study of a prospective cohort of guselkumab-initiating Crohn's Disease (CD) and Ulcerative Colitis (UC) patients to identify new or incident spondyloarthritis. This study will include adult patients aged 18-75 with IBD who are undergoing guselkumab intravenous or subcutaneous induction over a 1-year timeframe.",[341,27],"Spondyloarthritis","2026-05-15",{"date":322,"type":39},{"date":320,"type":21},{"date":346,"type":21},"2029-05-20",{"name":348,"class":46},"NYU Langone Health",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},"100574100","phase-1-clinical-trial-of-tqh3906-capsules-for-the-treatment-of-adult-patients-with-moderately-to-severely-active-ulcerative-colitis-or-crohns-disease-100574100","NCT06754891","Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","A Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 in Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Age between 18-75 years (inclusive of both 18 and 75), regardless of gender.\n* Diagnosed with ulcerative colitis or Crohn's disease for ≥3 months, as assessed by histological or endoscopic examination prior to screening.\n* Active moderate to severe UC or CD.\n* Subjects must have failed at least one of the following drug treatments for UC or CD or be intolerant: oral aminosalicylates, oral corticosteroids, immunosuppressants, biologics, etc.\n* If subjects are using the following drugs for UC or CD at the time of screening, their treatment should be stabilized with oral aminosalicylates for at least 3 weeks before the first dose of the trial medication, or stabilized with oral systemic corticosteroids for at least 2 weeks before the first dose of the trial medication, and maintain a stable dose during the trial period.\n* If oral aminosalicylate or combined hormone therapy has been discontinued recently, it must be discontinued for at least 2 weeks prior to the pre-randomization endoscopy.\n* Subjects (including partners) are willing to voluntarily take appropriate and effective contraceptive measures from the time of screening until 3 months after the last administration of the study medication.\n* Before the trial, understand in detail the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial, understand the research procedures, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Lesions confined solely to the rectal segment within 15 cm of the anus.\n* Subjects diagnosed with indeterminate colitis, radiation colitis, or ischemic colitis.\n* Presence of severe complications such as local stricture, intestinal obstruction, intestinal perforation, major lower gastrointestinal hemorrhage, intestinal neoplastic changes or neoplastic potential, toxic megacolon; rectal\u002Fcolonic polyps, or anal diseases that the investigator assesses may impact efficacy and safety evaluation.\n* Subjects with current stomas, ileostomy-anal anastomoses, or fistulas, where the physician determines surgery or medical intervention may be required within 12 weeks of study entry, or where ileostomy or colostomy may be necessary.\n* Subjects with extensive small bowel resection (\\>100 cm) or diagnosed short bowel syndrome, or requiring total parenteral nutrition.\n* Subjects with documented positive Clostridium difficile toxin (C. difficile) testing or polymerase chain reaction (PCR) testing.Polymerase Chain Reaction (PCR) test. If positive, the subject may be rescreened after appropriate treatment and retested no earlier than 7 days after treatment completion.\n* Patients with confirmed cytomegalovirus-associated colitis must have undergone adequate treatment for at least 3 months prior to the screening endoscopy and must be symptom-free.\n* Presence of abnormal seroviral status during the screening period:\n\na Active hepatitis, or hepatitis B surface antigen (HBsAg) positive with Hepatitis B Virus (HBV) DNA positive, or hepatitis B core antibody (HBcAb) positive with HBV-DNA positive, or Hepatitis C Virus (HCV) antibody positive with HCV-RNA positive; b Screening-period HIV antibody positive, or prior history of HIV infection; c. Positive treponemal antibody during screening without positive treponemal serological test (RPR or TRUST).\n\n* History of active tuberculosis during screening or prior to enrollment, or detection of latent tuberculosis infection during screening (defined as T-cell Spot of Tuberculosis (T-SPOT.0) positive without clinical manifestations). (Note: Patients with latent tuberculosis infection may initiate preventive treatment according to guidelines for 1 month. To continue in the study, patients must agree to complete the prophylactic treatment regimen during the study period, avoiding rifampin therapy.\n* History of severe herpes zoster or herpes simplex infections, including but not limited to herpes encephalitis, disseminated herpes simplex, or generalized herpes zoster.\n* History of severe bacterial, fungal, or viral infection requiring hospitalization with intravenous antibiotics or antiviral therapy within 2 months prior to first dosing.\n* Receipt of live vaccine within 4 weeks prior to first dosing or planned administration of live vaccine during the study period.\n* Development of clinically significant infection during the screening period, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, or herpes zoster requiring antibiotic or antiviral treatment.\n* Presence of any major disease or unstable clinical condition (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurological, immunologic, or locally active infection\u002Finfectious disease) deemed by the investigator to make participation in this study inappropriate.\n* Suffering from angina pectoris, arrhythmia, or congestive heart failure requiring medication, or exhibiting clinically significant abnormalities on screening ECG.\n* Abnormal screening laboratory tests:\n\n  i. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times upper limit of normal (ULN); a Hemoglobin \\\u003C 90 g\u002FL; b White blood cell count \\\u003C 3.0 × 10⁹\u002FL; c Neutrophil count \\\u003C 1.0 × 10⁹\u002FL; d Lymphocyte count \\\u003C 0.5 × 10⁹\u002FL; e Platelet count \\\u003C 100 × 10⁹\u002FL; f Total bilirubin \\> 2 times ULN; g Other significant laboratory abnormalities deemed by the investigator to make the subject unsuitable for this study.\n* Subjects with poorly controlled diabetes or diabetes with major complications (e.g., retinopathy or nephropathy).\n* History of malignancy (including carcinoma in situ) or lymphoproliferative disorders within 5 years prior to first dosing.\n* Within 8 weeks or 5 half-lives (whichever is longer) prior to the first dose, patients must have received ≤2 classes of biologics (e.g., anti-Tumor Necrosis Factor-alpha (TNF-α) agents are considered 1 class), including but not limited to anti-TNF-α and anti-α4β7 integrin agents.\n* Patients who have received Janus Kinase (JAK) inhibitors or other small molecule inhibitors (excluding those targeting Tyrosine Kinase 2 (TYK2) or TYK2\u002FJAK1) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose may be enrolled if the washout period is satisfied.\n* Previously received treatment with small-molecule drugs targeting the same TYK2 or TYK2\u002FJAK1 target.\n* Received fecal microbiota transplantation, cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, immunosuppressants, or similar medications within 4 weeks prior to first dose.\n* Received any other investigational drug within 1 month or 5 half-lives (whichever is longer) prior to the first dose.\n* Underwent surgery within 4 weeks prior to the first dose, or plans to undergo surgery during the study period.\n* Received immunoglobulin or blood products within 4 weeks prior to the first dose.\n* Use of potent CYP450 inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) within 4 weeks prior to first dose.\n* Use of topical therapy (enemas or suppositories), intravenous corticosteroids, anti-UC or CD traditional Chinese medicine, anti-infective agents, or antidiarrheal medications.\n* Received nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to first dose (excluding topical NSAIDs and low-dose aspirin for cardiovascular protection).\n* Organ transplant recipients requiring ongoing immunosuppressive therapy.\n* Known allergy to any component of TQH3906 or history of severe drug hypersensitivity.\n* History of substance abuse or positive urine drug screen.\n* Any other reasonable medical, psychiatric, or social reason deemed by the investigator to preclude participation in this study.",{"count":357,"type":21},135,[289],"This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and Pharmacokinetics\u002FPharmacodynamics (PK\u002FPD) characteristics of TQH3906 capsules in subjects with moderate-to-severe active ulcerative colitis. The study will include a maximum 4-week screening period, a 12-week treatment period, and a 4-week post-treatment follow-up period, enrolling a total of 105 subjects. Among these, subjects who failed conventional therapy and those who failed biologic therapy each constitute 35% of the cohort.\n\nweek treatment period, and a 4-week post-treatment follow-up period. A total of 105 subjects will be enrolled, with 50% comprising subjects who failed conventional therapy and 50% comprising subjects who failed biologic therapy.\n\nDose Group Design:\n\nGroup A: Placebo Group B: 32mg dose group Group C: 24mg bid dose group The specific dose will be determined based on the 48mg dose group's medication experience from Phase I and adjusted as necessary.",[27],"2026-05-07",{"date":363,"type":39},"2026-05-12",{"date":365,"type":39},"2025-01-28",{"date":367,"type":21},"2027-12",{"name":369,"class":73},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",30,{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":379,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":4},"100626128","phase-2-duloxetine-in-inflammatory-bowel-diseases-100626128","NCT07431606","Duloxetine in Inflammatory Bowel Diseases","A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress","Duloxetine in","Inclusion Criteria:\n\n* Adults over 24 years old; (younger patients are excluded because antidepressants have been shown to increase the risk of suicidal thinking and behavior in patients ≤ 24 years old.)\n* At least one of the following:\n\n  1. elevated psychological distress (Distress Thermometer score \\> 4),10-12\n  2. moderate-to-severe IBD-related disability (IBD-DI score ≥ 356, 7), or\n  3. elevated GI-specific anxiety (Visceral Sensitivity Index \\> 10) -\n\nExclusion Criteria:\n\n* Concomitant use of antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, buspirone, and thioridazine).\n* Initiation of psychotherapy within 8 weeks.\n* Inability or unwillingness to monitor ambulatory blood pressure and receive a blood pressure monitor via postal mail.\n* Cirrhosis with clinically evident hepatic insufficiency (Child-Pugh Class B or C) by medical record review.1\n* Severe renal impairment (on dialysis; chronic kidney disease stage 4-5; acute kidney injury with glomerular filtration rate \\\u003C30 mL\u002Fminute) by medical record review of labs performed within 18 months.\n* Concurrent participation in another clinical trial of an investigational medicinal product.\n* Pregnant or lactating either by self-report or medical record review\n* Glaucoma\n* Gastroparesis\n* Use of medications that could lead to serious interactions with the study medication: potent CYP1A2 inhibitors, antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, buspirone, thioridazine), linezolid, intravenous methylene blue, triptans, lithium, fentanyl, tramadol, meperidine, methadone, tryptophan, amphetamines, and St. John's Wort.\n* Bipolar, psychotic, alcohol use disorder, non-alcohol substance-induced disorders, or imminent danger to self or others","24 Years",{"count":381,"type":21},32,[59],"This open-label, prospective, single-arm pilot study investigates the use of duloxetine, a central neuromodulator, for improving psychological distress and functional impairment in adults with inflammatory bowel disease (IBD). The study focuses on patient-reported outcomes related to anxiety, depression, and IBD-related disability, aiming to assess feasibility, tolerability, and preliminary efficacy in modulating gut-brain axis symptoms and disease-related functional impairments in life",[27],"2026-04-30",{"date":387,"type":39},"2026-05-04",{"date":389,"type":21},"2026-05-01",{"date":391,"type":21},"2027-10-31",{"name":393,"class":46},"University of Pennsylvania",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100538121","phase-2-faecal-microbiota-transplantation-in-primary-sclerosing-cholangitis-100538121","NCT06286709","FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis","FARGO: A Randomised, Phase IIa, Multi-centre, Placebo-controlled Trial of FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis","FARGO","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Participants must be able to understand and comply with the purpose and procedures that are involved in the trial\n4. An established diagnosis of colonic inflammatory bowel disease, with willingness to participate in an annual colonoscopic surveillance program, as per routine standard of care\n5. An established clinical diagnosis of large duct PSC, with compatible features as assessed by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)\n6. A persistent ALP value above normal (at least 2 readings at this value over 6 months before screening)\n7. Evidence of early to moderate stage liver fibrosis, as suspected by any of the following:\n\n   1. Median VCTE score of ≤14.4kPa, with an interquartile range ≤30%\n   2. Previous liver biopsy indicating at an absence of established cirrhosis, Ishak fibrosis stage \\\u003CIV (or equivalent) in the last 24 months\n   3. Serum enhanced liver fibrosis score (ELF) ≤9.8\n8. A colonoscopy showing no evidence of dysplasia\u002Fneoplasia within 24 months before screening\n9. No evidence of active colitis, as evidenced by a Partial Mayo Score of ≤4, with a score of \\\u003C2 on the rectal bleeding domain at screening\n10. Individuals with IBD who are receiving treatment with biologics, immunosuppression or corticosteroids must be taking a stable dose for at least twelve weeks prior to screening, and be expected to remain on the same medication\u002Fsame dose for the duration of the trial\n11. Individuals with PSC having overlapping features of autoimmune hepatitis may be included, provided:\n\n    1. The dosage of immunosuppression has remained stable for at least twelve weeks prior to screening, and be expected to remain on the same medication\u002Fsame dose for the duration of the trial; and\n    2. There is evidence of concomitant colitis\n\nExclusion Criteria:\n\n1. Secondary causes of sclerosing cholangitis including, but not limited to, IgG4-related cholangitis, cholangiopathy due to acquired immunodeficiency syndrome, drug-induced sclerosing cholangitis, trauma, ischaemic cholangiopathy, choledocholithiasis (investigator discretion), or sclerosing cholangiopathy as a sequelae of hepatopancreatobiliary resection\n2. Other causes of liver disease, including, but not limited to, IgG4-related disease; viral hepatitis; alcohol-related liver disease; clinically significant metabolic associated fatty liver disease (at investigator discretion); drug-induced liver disease; hereditary haemochromatosis; alpha-1-antitrypsin disease; primary biliary cholangitis; Wilson disease; Budd-Chiari Syndrome; or primary or secondary hepatopancreatobiliary cancer\n3. Presence of a clinically significant dominant stricture based on the combination of radiological, biochemical and clinical features. Patients can be included in the trial with a dominant extrahepatic stenosis if it has been stable for 6 months or more (as evidenced on imaging and also clinically), and one of the following are satisfied:\n\n   1. The PI does not plan for any biliary intervention (endoscopic, percutaneous or surgical) for the duration of the trial OR\n   2. The investigator decides that they do not wish to perform any biliary intervention (endoscopic, percutaneous or surgical) on the dominant stenosis for clinical reasons of stability\u002Fpatient choice\n4. Presence of a percutaneous drain or bile duct stent\n5. Evidence of hepatic decompensation within twelve weeks prior to screening; or concern by the Principal Investigator that the participant may decompensate during the trial period. Hepatic decompensation as evidenced by variceal haemorrhage, ascites, hepatic hydrothorax, or hepatic encephalopathy (Appendix 1)\n6. Biochemical\u002Flaboratory evidence of very advanced hepatic dysfunction, as evidenced by a serum bilirubin value \\>55 µmol\u002FL (unless Gilbert Syndrome or another condition associated with unconjugated hyperbilirubinaemia, including but not limited to, spherocytosis and disorders of bilirubin conjugation where a bilirubin value\\>45 µmol\u002FL is allowable), serum albumin \\\u003C32 g\u002FL, platelet level of \\\u003C140x109\u002FL, Child-Turcotte-Pugh (CTP) score \\>B7, or a MELD score \\>15\n7. Ascending cholangitis as assessed clinically within twelve weeks of screening\n8. Use of antibiotics within twelve weeks of screening\n9. Participant already listed for liver transplantation, or concerns (investigator discretion) that they may need to be listed for liver transplantation during the trial period\n10. Small duct PSC\n11. Advanced-stage liver fibrosis, as evidenced by a VCTE score \\>14.4kPa, a liver biopsy showing \\>Ishak stage III fibrosis (or equivalent)\n12. Significant renal dysfunction as evidenced by an estimated glomerular filtration rate of \\\u003C60 ml\u002Fmin according to the Cockcroft-Gault formula, or need for dialysis\n13. Human Immunodeficiency Virus (HIV) infection\n14. A symptomatic positive test result for Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the four weeks prior to screening\n15. History of malignancy within the past three years, or ongoing malignancy, other than non-melanomatous skin cancer, or treated cervical carcinoma in situ\n16. Any history of small bowel or colonic resection, or likelihood of resection during the trial period. Individuals with a sub-total colectomy and ileal pouch anal anastomosis are permitted to participate.\n17. Patients who are pregnant or breastfeeding\n18. Women of childbearing potential (see Appendix 2 for definition) who confirm they are not willing to practise effective contraception (see Appendix 3 for further details) for the duration of the trial and for four weeks after the last dose of trial drug. Women who are taking hormonal contraception must confirm stable formulation and dosage for at least 6 weeks prior to treatment\n19. Alcohol consumption \\>21 units per week for men, and \\>14 units per week for women.\n20. Positive urine drug screen at screening\n21. Positive stool test for Clostridioides Difficile toxin or microscopy\u002Fculture positivity for enteric infection within twelve weeks prior to screening\n22. Participation in an interventional trial, or use of a non-licensed investigational agent for any indication within twelve weeks before screening, or five half-lives of the investigational drug, whichever is longer\n23. Newly introduced or a change in dosage of any of the following medications within twelve weeks of screening: fibric acid derivatives, farnesoid X-receptor agonists, anti-gastrointestinal motility agents (e.g., loperamide or opioids), bile acid sequestrants (e.g. colestyramine) or ursodeoxycholic acid (UDCA)\n24. Use of any of the following medications within twelve weeks of screening: oral or intravenous antibiotics, including (but not limited to) vancomycin, rifaximin, rifampicin and metronidazole; probiotic or prebiotic preparations, including (but not limited to) VSL#3 and Symprove",{"count":403,"type":21},58,[59],"FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease.",[407,27],"Primary Sclerosing Cholangitis","2026-04-28",{"date":410,"type":39},"2026-04-29",{"date":412,"type":39},"2024-03-27",{"date":414,"type":21},"2027-02-28",{"name":416,"class":46},"University of Birmingham",5,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":47},"100523355","ibd-sleep-a-pilot-study-looking-at-changes-in-sleep-timing-and-ibd-symptoms-100523355","NCT06094608","IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms","Inclusion Criteria:\n\n* Biopsy-proven IBD\n* Active IBD symptoms\n* Impaired IBD quality of life\n* Age \\>\u002F=18 years old\n* Fluency in English\n* Physically able to travel for study visits\n\nExclusion Criteria:\n\n* Ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses, are planned for imminent surgery and\u002For have short bowel syndrome\n* Other significant chronic disease\n* Retinal pathology, history of eye surgery, taking photosensitizing medications\n* Recent history of light treatment\n* Lifetime psychotic or bipolar disorder\n* Acute suicidal ideation\n* Substance use disorder in the past 3 months, cannabis use \\>1\u002Fweek\n* High risk for or diagnosed with obstructive sleep apnea, and\u002For narcolepsy\n* Severe hearing problem, intellectual disability or serious cognitive impairment\n* Pregnant, trying to get pregnant, or breastfeeding\n* Night work or travel outside the eastern time zone in the past month",{"count":167,"type":21},[24],"This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.",[27,28,29],"2026-04-23",{"date":430,"type":39},"2026-04-27",{"date":432,"type":39},"2024-02-01",{"date":434,"type":21},"2027-06-30",{"name":45,"class":46},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":445,"conditions":446,"keywords":447,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":47},"100489430","predictors-of-prognosis-in-ibd-patients-100489430","NCT05653011","Predictors of Prognosis in IBD Patients","Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal","Inclusion Criteria:\n\n* control group: Patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma)\n* TNF-α inhibitor-naive IBD group: IBD patients who do not have a history of TNF-α inhibitor treatment\n* TNF-α inhibitor-treated IBD group: IBD patients who are treated with TNF-α inhibitor\n\nExclusion Criteria:\n\n* Age under 18 years\n* Patients who were treated with antibiotics or probiotics within the last 3 months",{"count":444,"type":21},100,"A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease",[27,28,29],[448,449,450],"inflammatory bowel disease","ulcerative colitis","crohn's disease",{"date":452,"type":39},"2026-04-24",{"date":454,"type":39},"2013-03-11",{"date":456,"type":21},"2026-12-31",{"name":458,"class":46},"Seoul National University Bundang Hospital",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":467,"enrollmentInfo":468,"targetDuration":470,"studyType":87,"phases":4,"briefSummary":471,"conditions":472,"keywords":482,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":47},"100540310","seattle-spatial-transcriptomic-research-in-inflammatory-bowel-disease-evaluation-stride-100540310","NCT06315179","Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)","Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation","STRIDE","Inclusion Criteria:\n\n* Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)\n\nExclusion Criteria:\n\n* Evidence of Other Complicating Medical Issues:\n* Other serious medical conditions, such as neurological, liver, kidney, or systemic disease\n* Pregnancy\n* Tobacco, alcohol, or illicit drug abuse","21 Years",{"count":469,"type":21},200,"3 Years","This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.",[27,29,28,473,474,475,476,477,478,479,480,481],"Indeterminate Colitis","Functional Abdominal Pain Syndrome","Functional Bowel Disorder","Esophageal Diseases","Gastroduodenal Disorder","Bowel Dysfunction","Gallbladder Diseases","Sphincter of Oddi Dysfunction","Anorectal Disorder",[247,483],"DGBI","2026-04-21",{"date":452,"type":39},{"date":487,"type":39},"2024-05-10",{"date":489,"type":21},"2030-01",{"name":491,"class":46},"Seattle Children's Hospital",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":498,"enrollmentInfo":499,"targetDuration":315,"studyType":87,"phases":4,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":47},"100634441","clinical-value-of-intestinal-ultrasound-in-predicting-clinical-relapse-in-crohns-disease-patients-in-deep-remission-a-multicenter-prospective-observational-study-100634441","NCT07539727","Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational Study","Inclusion Criteria:\n\n* Patients previously diagnosed with Crohn's disease via endoscopy and histopathology at other hospitals or at our institution; patients aged 18-70 years; Complete clinical data and biochemical parameters are available for the week before and after endoscopy, including comprehensive patient demographics and laboratory indicators such as complete blood count, liver function, kidney function, CRP, and ESR; a color Doppler ultrasound of the intestines was performed at our hospital within one week before or after endoscopy, and the relevant records are complete; patients assessed to have achieved deep remission based on endoscopic and other data.\n\nExclusion Criteria:\n\n* Patients with concomitant colorectal cancer; patients with severe cardiovascular, respiratory, or urinary dysfunction; pregnant or lactating women; patients younger than 16 or older than 70 years of age; patients who changed their maintenance therapy regimen upon achieving deep remission; patients with incomplete medical records, such as color Doppler ultrasound of the intestines.","70 Years",{"count":500,"type":21},420,"Crohn's disease (CD) is a nonspecific chronic inflammatory condition characterized by a protracted course with alternating periods of relapse and remission. Even patients who achieve deep remission remain prone to recurrence and require long-term follow-up. While various monitoring methods are available, endoscopy plays a primary role in the management and diagnosis of CD; however, its relative invasiveness and the need for bowel preparation limit the feasibility of continuous monitoring. In contrast, transabdominal intestinal ultrasound offers advantages such as non-invasiveness, absence of radiation, good patient tolerance, and low cost, making it suitable for long-term monitoring. However, most studies have focused on exploring its concordance with disease activity and endoscopic findings, with only a limited number of studies examining its clinical significance for long-term prognosis.\n\nTherefore, we conducted a multicenter prospective study involving 18 months of follow-up in CD patients who achieved deep remission. Based on the follow-up results, patients were divided into relapse and non-relapse groups. Stratified analysis was performed according to the Montreal classification to compare color Doppler ultrasound parameters between the two groups and within each stratum, and to establish a predictive model.",[27],"2026-04-13",{"date":505,"type":39},"2026-04-20",{"date":507,"type":39},"2025-01-01",{"date":509,"type":21},"2029-01-01",{"name":511,"class":46},"Nanfang Hospital, Southern Medical University",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":17,"minAge":520,"maxAge":18,"enrollmentInfo":521,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":559,"locationsCount":561},"100608173","compare---pediatric-inflammatory-bowel-disease-pibd-100608173","NCT07198113","COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)","Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD","COMPARE","Inclusion Criteria:\n\n* Age \\\u003C 18 years at study enrollment\n* Diagnosis of CD, UC, or IBD-U by standard diagnostic criteria\n* Prior non-response or loss of response to one or more anti-TNF agents\n* Planning to initiate treatment with any of the following comparator agents: vedolizumab (α4β7 integrin antibody), ustekinumab (anti-IL-12\u002F23 antibody), risankizumab, guselkumab, or mirikizumab, (IL-23 inhibitors), tofacitinib (JAK inhibitor), and upadacitinib (JAK inhibitor). Biosimilars or generic medications for any of the above will also be allowed and handled\u002Fanalyzed in an identical manner to originators.\n* Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish\n\nExclusion Criteria:\n\n* Plans to change care to a different center within 1 year\n* Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)\n* Contraindication to any of the treatments under investigation\n* Patients with UC or IBD-U who have undergone colectomy\n* Patients with current ostomy","1 Year",{"count":522,"type":21},1100,"The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is:\n\nAre the newer medications used to treat IBD just as safe and effective for treating IBD in children.\n\nParticipants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.",[525,27,29],"Ulcerative Colitis, Pediatric",[527,528,247,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,518],"Ulcerative colitis, pediatric","Inflammatory bowel disease, pediatric","CD","UC","PIBD","Pediatrics","Children","Anti-TNF","Vedolizumab","Ustekinumab","Risankizumab","Guselkumab","Mirikizumab","Tofacitinib","Upadacitinib","Patient-reported outcomes (PROs)","Tumor necrosis factor antagonists","IL-23 agent","PCORI","PCORnet","DCRI","Duke","UNC","University of North Carolina","Observational cohort","Anti-tumor necrosis factor (TNF) refractory","Comparative Effectiveness Research (CER)",{"date":555,"type":39},"2026-04-17",{"date":557,"type":39},"2025-11-01",{"date":186,"type":21},{"name":560,"class":46},"University of North Carolina, Chapel Hill",4,{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":498,"enrollmentInfo":569,"targetDuration":4,"studyType":22,"phases":571,"briefSummary":572,"conditions":573,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":47},"100619811","phase-2-pentoxifylline-in-patients-with-ulcerative-colitis-100619811","NCT07349472","Pentoxifylline in Patients With Ulcerative Colitis","Clinical Study Evaluating Safety and Efficacy of Pentoxifylline in Patients With Ulcerative Colitis","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Both male and female will be included\n* Negative pregnancy test and effective contraception.\n* Mild and moderate UC patients\n\nExclusion Criteria:\n\n* Breast feeding\n* Significant liver and kidney function abnormalities\n* Diabetic patients\n* Colorectal cancer patients\n* Patients with severe UC\n* Patients taking rectal or systemic steroids\n* Patients taking immunosuppressives or biological therapies\n* Addiction to alcohol and \u002F or drugs\n* Known allergy to the studied medications",{"count":570,"type":21},60,[59],"Ulcerative colitis (UC) is a persistent, idiopathic form of inflammatory bowel disease (IBD) marked by uninterrupted inflammation of the colon's mucosal lining, usually starting at the rectum and progressing proximally in a continuous manner. It manifests clinically with recurrent episodes of abdominal pain, bloody diarrhea, urgency, tenesmus, and weight loss. The precise cause of UC is still unknown; however, it is thought to arise from a multifactorial interaction involving genetic susceptibility, immune system dysregulation, disturbances in gut microbiota composition, and various environmental factors.",[27],"2026-04-11",{"date":576,"type":39},"2026-04-15",{"date":578,"type":39},"2026-01-20",{"date":580,"type":21},"2027-02-20",{"name":582,"class":46},"Ihab Elsayed Hassan",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":591,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":47},"100606430","ibdminds---mapping-the-influence-of-anxiety-and-depression-on-ibd-100606430","NCT07175454","IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD","A Study to Describe the Burden of Mental Ill Health in Inflammatory Bowel Disease Patients Using Advanced Therapies, and to Identify Any Associations Between Common Mental Health Problems and the Efficacy of Such Advanced Therapies (IBDmind)","IBDminds","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of ulcerative colitis, or Crohn's disease, based upon either the outcome of the local multidisciplinary team, clinic documentation or in the opinion of the investigator\n* Patients receiving maintenance infliximab or vedolizumab by regular intravenous infusion\n* Patients willing and able to give informed consent\n* Patients aged 16 or over\n\nExclusion Criteria:\n\n* Patients cannot be recruited while receiving their loading dose of infusions, but may be included once complete.\n* Patients should not currently be planned for surgery within the next 12 months\n* Patients should not currently be planned to switch to another advanced therapy within the next 12 months\n* Patients should not currently be planned for a drug holiday within the next 12 months\n* Patients should not have a stoma (This would invalidate the PRO-2 outcome measure)\n* Patients should not currently be pregnant\n* Patient currently receiving subcutaneous infliximab or vedolizumab","16 Years",{"count":593,"type":21},450,"People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common. People often get IBD in their teens or twenties. They often find working, studying and relationships hard. IBD can't be cured, so it lasts for life.\n\nWhen IBD is hard to treat, we use advanced treatments, but these don't always work. When they do work the effect can wear off. This happens in 2 of 5 people within a year in research studies. There are some things that we know make them wear off. There are lots more reasons that we don't understand yet. We think anxiety, depression and stress make these treatments more likely to wear off. Previous research has suggested that people with IBD do worse if they have anxiety, depression or stress.\n\nThe investigators want people with IBD to complete questionnaires to see if they are affected by anxiety, depression or stress when they are taking advanced therapies. The investigators will follow those people to see if the effect of their treatment wears off.\n\nPeople living with IBD will contribute to the running and fine tuning of this research. Many of those that have engaged with us so far have said that their disease was worse when their mental health was worse. They were generally supportive of this study to see how anxiety, depression and stress effects IBD in people using advanced therapies.\n\nThe investigators have talked to a national charity about our work. They will help share the findings so that patients, care givers and other stakeholders will be able to read about them. The results will be published so that doctors and researchers can use them.",[27,596],"Mental Health Issue","2026-04-08",{"date":599,"type":39},"2026-04-09",{"date":601,"type":21},"2026-05",{"date":603,"type":21},"2028-05",{"name":605,"class":606},"The Royal Wolverhampton Hospitals NHS Trust","OTHER_GOV",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":591,"maxAge":195,"enrollmentInfo":613,"targetDuration":4,"studyType":22,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":47},"100558587","acupuncture-reduces-relapse-in-patients-with-crohns-disease-a-superiority-trial-100558587","NCT06553053","Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial","Inclusion Criteria:\n\n1. patients with clinical diagnosis consistent with CD;\n2. aged 16-75;\n3. patients in remission (CDAI \\\u003C 150 and CRP \\\u003C 5mg\u002Fl, or Faecal calprotectin \\\u003C 50μg\u002Fg, or no ulcer under endoscopy);\n4. patients with frequent disease recurrences (≥2) in the past years;\n5. patients were not taking medication or were only taking one or more of the following drugs: \\[mesalazine (≤4g\u002Fd), prednisone (≤15mg\u002Fd), azathioprine (≤1mg\u002Fkg\u002Fd)\\] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);\n6. those who have never experienced acupuncture;\n7. patients signing informed consent.\n\nExclusion Criteria:\n\n1. patients who are recently pregnant or in pregnancy or lactation;\n2. patients with serious organic diseases;\n3. patients diagnosed as psychosis;\n4. patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;\n5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;\n6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;\n7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;\n8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.",{"count":614,"type":21},106,[24],"The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.",[618,27],"Crohn's Disease Relapse",{"date":503,"type":39},{"date":621,"type":39},"2024-08-13",{"date":623,"type":21},"2028-12-31",{"name":625,"class":46},"Shanghai Institute of Acupuncture, Moxibustion and Meridian",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":467,"enrollmentInfo":633,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":634,"conditions":635,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":641,"locationsCount":47},"100521102","therapeutic-endpoint-in-pediatric-ibd-conditions-100521102","NCT06065228","Therapeutic Endpoint in Pediatric IBD Conditions","Development of a Therapeutic Endpoint in Pediatric IBD Conditions","Inclusion Criteria:\n\n* Male or female ≥ 6 years of age at screening.\n* Documentation of an IBD diagnosis as evidenced by history\n\nExclusion Criteria:\n\n* Documented history of eye disease precluding pupillometry\n* Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.",{"count":570,"type":21},"The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.",[27,63,29],"2026-04-03",{"date":597,"type":39},{"date":639,"type":39},"2023-11-27",{"date":367,"type":21},{"name":642,"class":46},"Children's National Research Institute"]