[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-bowel-disease-ibd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-bowel-disease-ibd":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,62,0,25,[9,43,55,88,108,134,161,185,221,246,269,295,322,348,377,406,435,464,491,512,533,552,581,605,692],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053793","phase-2-study-of-disc-0974-201-in-participants-with-ibd-and-anemia-100053793",false,"NCT07368972","Study of DISC-0974-201 in Participants With IBD and Anemia","RALLY-IBD: A Phase 2 Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of DISC-0974 in Participants With Inflammatory Bowel Disease and Anemia of Inflammation","Inclusion Criteria:\n\nParticipants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study:\n\n1. Aged ≥18 years at the time of signing informed consent.\n2. Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented findings on both endoscopy and histopathology.\n3. Baseline endoscopy at screening with modified Mayo Score for UC and CDAI for Crohn's Disease to include mild disease as defined below:\n\n   a. CDAI of \\\u003C220 and SES-CD of 0 to 6 (CD\u002FIBD-unclassified) modified Mayo Score of \\\u003C5 points and Mayo endoscopic subscore of 0 to 1 (UC\u002FIBD-unclassified).\n4. Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.\n5. Hgb ≥7 AND \\\u003C12 g\u002FdL for females and ≥7 AND \\\u003C13 g\u002FdL for males (local lab) at screening.\n6. Have symptomatic anemia defined as:\n\n   1. Hgb ≤10 g\u002FdL and symptomatic as assessed by Investigator (fatigue, shortness of breath at rest or on minimal exertion, palpitations, tachycardia, orthostatic hypotension or dizziness), or\n   2. Hgb \\>10 g\u002FdL and a minimum score of 4 on the Numeric Rating Scale for Fatigue.\n7. Serum ferritin ≥75 μg\u002FL at screening (local lab).\n8. AST and ALT \\\u003C2× upper limit of normal (ULN) at screening.\n9. Total and direct bilirubin \\\u003CULN at screening.\n10. Estimated glomerular filtration rate ≥30 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.\n11. If female, then EITHER postmenopausal (defined as at least 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) \\>40 mIU\u002FmL, or at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) during the study and for at least 8 weeks after the last dose of study drug:\n\n    * Stable hormonal contraceptive (≥3 months)\n    * Intrauterine device in place for at least 3 months\n    * Tubal ligation or single male partner with vasectomy\n12. If a male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    * Stable hormonal contraceptive (≥3 months; female partner)\n    * Intrauterine device in place for at least 3 months (female partner)\n    * Surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    * Confirmed successful vasectomy\n13. Able to understand and provide written informed consent.\n14. Able to comply with all study procedures.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria at screening are not eligible for study enrollment:\n\n1. Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to screening labs for oral iron or iron-containing supplements. Between screening and 2 days prior to Day 1 visit, participants may continue oral iron or iron-containing supplements at the discretion of the Investigator, but any study-related lab draws will require a 48-hour washout from oral iron.\n2. Treatment within 30 days prior to screening with any of the following anemia treatments: blood transfusion, EPO-stimulating agent (ESA), or IV iron. Participants may be considered for the study if they undergo a 30-day washout period for ESAs or IV iron prior to screening labs.\n3. Planned change in IBD directed therapy within 3 months of screening.\n4. Moderate or severe IBD assessed during screening period. Defined as:\n\n   1. CD\u002FIBD-unclassified: participants with a CDAI score ≥220 or SES-CD ≥7\n   2. UC\u002FIBD-unclassified: modified Mayo Score of ≥6 or endoscopic subscore of 3\n   3. Fever, tachycardia, or anticipated need for surgery in the next 3 months\n5. Hospitalization within 30 days prior to screening.\n6. Positive direct antiglobulin test with reactive eluate at screening or medical history at screening of active hemolytic anemia.\n7. Gross gastrointestinal blood loss (eg, visible rectal bleeding, hematochezia, melena) within 4 weeks prior to screening.\n8. Active gastrointestinal bleeding requiring hospitalization, blood transfusion, or endoscopy hemostasis within 8 weeks prior to screening.\n9. Current use of Janus kinase (JAK) inhibitor.\n10. History of hereditary hemochromatosis.\n11. History of Primary Sclerosis Cholangitis.\n12. History of hemoglobinopathy or intrinsic RBC defect associated with anemia.\n13. History of total splenectomy.\n14. Hematopoietic stem cell or solid organ transplant within the past 10 years.\n15. Medical history of anemia from Vitamin B12 or folate deficiency or infection in the 3 months prior to screening.\n16. Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to screening.\n17. Medical history of clinically significant thrombotic disorder.\n18. If female, pregnant or breastfeeding.\n19. Any major surgery within 8 weeks before screening or incomplete recovery from any previous surgery.\n20. Current or recent systemic corticosteroid use (within 3 months of screening).\n21. Endoscopic abnormalities concerning for colon cancer on baseline endoscopy.\n22. History of malignancy within the last 3 years. The following history\u002Fconcurrent conditions are allowed: basal or squamous cell carcinoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis clinical staging system). A history of completed treatment (medical or surgical) of Stage 1-2 cancers may be permitted with prior Sponsor agreement.\n23. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days of screening.\n24. A history or known allergic reaction to any investigational product excipients.\n25. History of ADA formation with anaphylaxis.\n26. History of inadequately controlled heart failure (New York Heart Association Classification 3 or 4) and\u002For have a history of left ventricular ejection fraction \\\u003C35%.\n27. Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement, despite appropriate treatment).\n28. Active infectious gastroenteritis including clostridium difficile colitis or viral enteritis (eg, cytomegalovirus).\n29. HIV positive, active hepatitis B virus surface antigen (HBV), or active hepatitis C virus antibody (HCV).\n30. Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study.\n31. Any condition or concomitant medication that would confound the ability to interpret data from the study.","ALL","18 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2, multicenter, randomized, double-blind placebo-controlled study of DISC-0974 to evaluate safety, tolerability, and efficacy in participants with IBD and anemia of inflammation.",[27,28,29],"Inflammatory Bowel Disease (IBD)","Anemia","Inflammatory Bowel Disease (IBD); Anemia","RECRUITING","2026-07-09",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-02-20",{"date":38,"type":21},"2027-03",{"name":40,"class":41},"Disc Medicine, Inc","INDUSTRY",13,{"id":44,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":22,"phases":46,"briefSummary":25,"conditions":47,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":53,"locationsCount":54},"100621311",{"count":20,"type":21},[24],[27,28,29],"2026-06-29",{"date":50,"type":34},"2026-06-30",{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},11,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100645256","biophysical-assessments-of-acupuncture-points-in-inflammatory-bowel-disease-100645256","NCT07681895","Biophysical Assessments of Acupuncture Points in Inflammatory Bowel Disease","Acupoint Sensitization in Inflammatory Bowel Disease: A Non-interventional Study","Inclusion Criteria (Adults with IBD):\n\n* adults (age 18 years or older)\n* clinical diagnosis of ulcerative colitis or Crohn's disease\n\nExclusion Criteria (Adults with IBD):\n\n* any history of serious musculoskeletal or soft tissue injury of the lower and\u002For upper extremities\n* presence of scarring or tattoo on the lower and\u002For upper extremities\n* presence of serious cardiac diseases, severe dermatological conditions, peripheral neuropathy, infectious disease, psychological illnesses, or other serious co-morbidities (e.g., cancer)\n* prior history of colostomy or ileostomy\n* pregnancy\n\nInclusion Criteria (Healthy control participants):\n\n\\- adults (age 18 years or older) in good health conditions\n\nExclusion Criteria (Healthy control participants):\n\n* history of chronic inflammatory diseases, such as IBD\n* severe digestive and\u002For intestinal conditions, such as irritable bowel syndrome (IBS)\n* any history of serious musculoskeletal or soft tissue injury of the lower and\u002For upper extremities\n* presence of scarring or tattoo on the lower and\u002For upper extremities\n* presence of serious cardiac diseases, severe dermatological conditions, peripheral neuropathy, infectious disease, psychological illnesses, or other serious co-morbidities (e.g., cancer)\n* pregnancy",true,{"count":64,"type":21},100,"OBSERVATIONAL","Acupuncture points or acupoints are fundamental to the practice of acupuncture, yet their scientific basis remains unclear. According to traditional explanations of acupuncture, acupoints can become tender or more sensitive to pressure when there is an underlying disease of the body. Findings from recent basic animal studies support this traditional theory. For example, compared to healthy control animals, models of colitis have shown increased skin temperature, blood flow, and pain sensitivity at specific body regions that correspond to the location of acupoints that are commonly used in acupuncture treatment for colitis. However, little is known about whether these findings apply to humans.",[27],[69,70,71,72,73,74,75,76],"Inflammatory bowel disease","IBD","Acupuncture point","Acupoint","Cutaneous neurogenic inflammation","Infrared thermography","Laser speckle contrast imaging","Pressure pain threshold","NOT_YET_RECRUITING","2026-06-27",{"date":80,"type":34},"2026-07-02",{"date":82,"type":21},"2026-08-01",{"date":84,"type":21},"2027-11-30",{"name":86,"class":87},"Brigham and Women's Hospital","OTHER",{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":106,"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":96,"type":21},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.",[99,27,100],"Crohn Disease","Colitis Ulcerative","2026-06-26",{"date":80,"type":34},{"date":82,"type":21},{"date":105,"type":21},"2027-06-30",{"name":107,"class":41},"LOGEX",{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100642703","prospective-evaluation-of-flare-detection-in-ibd-with-digital-biomarkers-bring-your-own-device-study-100642703","NCT07647640","Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study","BYOD","Inclusion Criteria:\n\n* 18 years or older\n* Crohn's Disease or ulcerative colitis\n* Having a smartwatch and\u002For a smartphone\n* Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)\n\nExclusion Criteria:\n\n* No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...",{"count":116,"type":21},600,"The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.",[27,119,120],"Ulcerative Colitis (UC)","Crohn Disease (CD)",[122,123,124],"Inflammatory Bowel Disease","Digital biomarkers","Heart rate variability","2026-06-24",{"date":48,"type":34},{"date":128,"type":21},"2026-06-15",{"date":130,"type":21},"2027-10-15",{"name":132,"class":87},"Maastricht University Medical Center",3,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":150,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100645017","a-pilot-study-using-gut-directed-hypnotherapy-for-hospitalized-patients-100645017","NCT07676136","A Pilot Study Using Gut-Directed Hypnotherapy for Hospitalized Patients","Inclusion Criteria:\n\n* Adults admitted to the GI inpatient service with expected length of stay \\>24 hours\n* Prior diagnosis of a disorder of gut-brain interaction, esophageal disorder, or inflammatory bowel disease\n* Reason for hospitalization related to symptom management for exacerbation of visceral pain and\u002For nausea.\n\nExclusion Criteria:\n\n* Currently using hypnosis\n* severe developmental delay or cognitive impairment\n* serious mental illness (i.e. psychosis or dissociation)\n* hearing impairment\n* Non-English speaking\n* enrolled in another trial for GI symptom management\n* admitted for GI procedure",{"count":141,"type":21},26,[143],"NA","The purpose of the study is to compare the effectiveness of recorded gut-directed hypnosis to an educational recording in people with chronic problems in their gastrointestinal (GI) system. Patients who are hospitalized at Stanford Hospital for worsening pain and\u002For nausea will be considered for enrollment.",[146,27,147,148,149],"Disorders of Gut-brain Interaction","Irritable Bowel Syndrome","Abdominal Pain","Esophageal Disease",[151],"hypnosis","2026-06-23",{"date":50,"type":34},{"date":155,"type":21},"2026-07",{"date":157,"type":21},"2028-07",{"name":159,"class":87},"Stanford University",1,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":160},"100577040","comparison-diagnostic-tests-for-the-diagnosis-of-cytomegalovirus-organ-disease-in-patients-with-intestinalbowel-diseases-100577040","NCT06793124","Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases","Comparison of Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With Intestinal BOweL Diseases","CYTO-BOLD","Inclusion Criteria:\n\n* Patients aged ≥18 years with Inflammatory Bowel Disease (IBD) with worsening of IBD-related symptoms requiring hospital admission\n* Signing of informed consent\n* Performed endoscopic biopsies to confirm\u002Fexclude CMV organ disease\n\nExclusion Criteria: \u002F",{"count":170,"type":21},200,"Observational, single-center, non-pharmacological, prospective study of adult patients affected by Inflammatory Bowel Disease (IBD) with an ongoing disease exacerbation requiring hospitalization",[173,27],"Cytomegalovirus (CMV)",[173,27,175,176],"PCR","Tissue biopsy","2026-06-11",{"date":128,"type":34},{"date":180,"type":34},"2024-04-02",{"date":182,"type":21},"2026-12-31",{"name":184,"class":87},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":219,"locationsCount":160},"100643523","aim-ibd-a-microbiome-targeted-supplement-in-mild-to-moderate-ulcerative-colitis-100643523","NCT07619638","AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis","AIM-IBD: A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of a Microbiome-Targeted Food Supplement Versus Placebo in Adults With Mild-to-Moderate, Objectively Active Ulcerative Colitis","AIM-IBD","Inclusion Criteria:\n\n1. Adults aged 18 to 75 years inclusive at screening.\n2. Documented diagnosis of ulcerative colitis established at least 3 months before screening, based on standard clinical, endoscopic, and histologic criteria.\n3. Mild-to-moderate active ulcerative colitis defined by a partial Mayo score of 4 to 8 at screening.\n4. Rectal bleeding subscore of at least 1 at screening.\n5. Objective intestinal inflammation defined by fecal calprotectin of at least 250 micrograms per gram at screening, measured by the central laboratory or by a validated harmonized assay.\n6. Eligible disease extent: left-sided colitis or extensive\u002Fpancolitis. Proctosigmoiditis is eligible if inflammation extends beyond isolated proctitis and is measurable by study endoscopy. Isolated ulcerative proctitis (E1 only) is eligible only within a prespecified cap not exceeding 10 percent of total enrollment.\n7. Either no current ulcerative colitis-directed therapy, or stable oral and\u002For rectal 5-aminosalicylate (5-ASA, mesalamine) therapy at unchanged dose for at least 8 weeks before randomization, with intent to continue at the same unchanged dose through Week 24 unless rescue therapy is clinically required.\n8. Able and willing to provide written informed consent.\n9. Able and willing to comply with study visits, stool sampling, endoscopy, medication restrictions, and diary\u002Fpatient-reported outcome completion.\n10. Participants of childbearing potential must agree to use a highly effective method of contraception during dosing and for at least 4 weeks after the last dose, in accordance with EMA\u002FCTFG guidance and local ethics requirements.\n\nExclusion Criteria:\n\n1. Crohn disease, inflammatory bowel disease-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or any other non-ulcerative-colitis form of colitis.\n2. Severe ulcerative colitis, acute severe ulcerative colitis, fulminant colitis, toxic megacolon, or any disease severity requiring immediate hospitalization or treatment escalation in the investigator's judgment.\n3. Isolated ulcerative proctitis (E1 only) outside the prespecified 10 percent enrollment cap.\n4. Use of biologics, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor modulators, or systemic immunosuppressants within 8 weeks before randomization, or planned use of any of these during the trial.\n5. Systemic corticosteroids within 4 weeks before randomization.\n6. Current budesonide-class therapy at baseline.\n7. Rectal or topical corticosteroids unless discontinued at least 2 weeks before randomization.\n8. Antibiotic use within 4 weeks before randomization, except topical antibiotics not expected to affect the gut microbiota.\n9. Probiotic, prebiotic, synbiotic, postbiotic, fermented microbiome-directed supplement, or other non-study microbiome-directed product within 4 weeks before randomization, or planned use during the trial.\n10. Active or recent Clostridioides difficile infection within 12 weeks before screening (screening uses a two-step algorithm: glutamate dehydrogenase plus toxin A\u002FB enzyme immunoassay, with reflex nucleic acid amplification testing for discordant results).\n11. Positive stool test for any clinically relevant enteric infection at screening, per local diagnostic standard operating procedures.\n12. Prior colectomy, planned colectomy, known dysplasia requiring intervention, or colorectal cancer.\n13. Pregnancy, breastfeeding, or planned pregnancy during the trial.\n14. Uncontrolled clinically significant comorbidity, including but not limited to uncontrolled diabetes, advanced liver or renal disease, unstable cardiovascular disease, immunodeficiency, active malignancy other than adequately treated non-melanoma skin cancer, or any other condition compromising participant safety or interpretation of study results.\n15. Known allergy, intolerance, or contraindication to any component of the investigational product or matching placebo.\n16. Participation in another interventional clinical trial within 30 days before screening.\n17. Any other condition that, in the investigator's judgment, would make participation unsafe or compromise protocol adherence.","75 Years",{"count":195,"type":21},162,[143],"This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with mild-to-moderate, objectively active ulcerative colitis. The supplement is food-grade and is intended for use either alongside stable standard ulcerative colitis therapy (5-aminosalicylic acid\u002Fmesalamine) or in participants not currently on any inflammatory bowel disease therapy.\n\nApproximately 162 participants will be enrolled at university hospital centers in Turkey and randomized in a 1:1 ratio to receive either the food supplement or matching placebo for 24 weeks, in addition to their existing background therapy as defined by eligibility.\n\nThe primary objective is to determine whether the supplement increases the proportion of participants achieving composite clinical-plus-biochemical remission at Week 24. This composite endpoint requires absence of rectal bleeding, improvement in stool frequency, fecal calprotectin ≤250 micrograms\u002Fg, and no rescue therapy, prohibited treatment escalation, ulcerative colitis-related hospitalization, colectomy, or discontinuation for lack of efficacy before Week 24.\n\nKey secondary endpoints include endoscopic improvement, deep biochemical remission, change in fecal calprotectin, change in partial Mayo score, corticosteroid-free composite remission, change in quality of life, change in C-reactive protein, time to treatment failure, and safety. Exploratory analyses will assess stool microbiome composition, eukaryotic carriage including Blastocystis, and associations between baseline microbiome features and treatment response.",[119,27,199],"Colitis",[201,69,202,203,204,205,206,207,208,209,210,211,212],"Ulcerative colitis","Microbiome","Gut microbiota","Fecal calprotectin","Artificial intelligence","Partial Mayo score","5-ASA","Mesalamine","Nutraceutical","Placebo-controlled trial","Blastocystis","Microbiome-targeting nutraceutical","2026-06-05",{"date":215,"type":34},"2026-06-09",{"date":217,"type":21},"2026-06-10",{"date":84,"type":21},{"name":220,"class":41},"ENBIOSIS BIOTECHNOLOGIES",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":229,"studyType":65,"phases":4,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100611202","zymfentra-infliximab-dyyb-real-world-cohort-study-100611202","NCT07237516","Zymfentra (Infliximab-dyyb) REal World Cohort STudy","ZEST","Inclusion Criteria:\n\n\\- 1. Adult patients, age 18 years or older, with Crohn's disease (CD), ulcerative colitis (UC) or Inflammatory Bowel Disease Unclassified (IBDU), who are either starting Zymfentra at week 10 (IFX-dyyb) in the setting of standard-of-care initiation with intravenous Infliximab (IFX) originator or IFX biosimilars induction therapy at weeks 0,2,6 or switching from intravenous IFX originator or IFX biosimilars during maintenance therapy to Zymfentra (IFX-dyyb) 2. Anticipation that the patient will be followed by the participating center for the next 12 months.\n\n3\\. Diagnosis of CD, UC or IBDU must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.\n\nThe following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with CD, UC or IBDU:\n\nA) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, complicated perianal disease, extraintestinal manifestations, weight loss or failure to thrive.\n\nAND B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. When there has been a single episode of colitis (in some instances less than 6 weeks duration) resulting in colectomy and resolution of disease symptoms, pathology on the colectomy specimen should be consistent with idiopathic IBD and microbiology studies should be negative.\n\nAND\n\nC) One or more of the following providing objective evidence of inflammation:\n\nEndoscopic: Mucosal edema, erythema, loss of normal submucosal vasculature, friability, ulceration, stricture formation, pseudopolyps, mucosal edema, erythema. Where there are only minor changes (mucosal edema, erythema, loss of normal submucosal vasculature, friability) mucosal biopsies should have been done to confirm the presence of IBD.\n\nRadiologic: Mucosal thickening and\u002For nodularity, ulceration, stricture, pseudopolyps, fistula formation, pseudosacculation. Minor changes alone (mucosal thickening and\u002For nodularity) should not be sufficient to make a diagnosis of IBD.\n\nHistologic: Mucosal erosion or ulceration, architectural changes of crypts, Paneth cell metaplasia (in colon), transmural inflammatory infiltrate\\*, fibrosis of muscularis propria\\*, noncaseating granuloma\\*.\n\n\\* CD\n\nIndividuals with IBD should be classified into one of three categories, based on most recent diagnosis:\n\nCrohn's disease (CD):\n\n1. Evidence of small intestinal inflammation with endoscopically, radiologically or histologically demonstrated ulcerations, fistulation, mucosal fissuring, nodularity or cobblestoning, stricture formation or histologically demonstrated transmural inflammation with or without granuloma formation.\n2. Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.\n3. Colonic inflammation which is patchy (normal segments separating areas of inflammation, as described above) or associated with one or more of the following features: complete rectal sparing, multiple (\\>10) aphthoid ulcers, deep ulceration (into the muscularis propria), transmural inflammation, extensive fibrosis and wall thickening, fistulation, non-caseating granuloma. (N.B. See note below regarding patchiness of endoscopically observed inflammation in patients with partially treated ulcerative colitis.)\n4. The presence of complex suppurative perianal disease (i.e. more than a superficial fistula or uncomplicated superficial abscess).\n5. If there are fewer than 10 aphthoid ulcers in the cecum (and the rest of the colon appears normal) in a patient with small bowel disease then this should be called small bowel disease only. Similarly, if the colon is normal except for the presence of a fistula extending from inflamed small bowel, the patient should be said to have small bowel disease alone. If the cecum is involved with ulcers larger than aphthoid ulcers or ulcers that are deep or if the involvement has resulted in deformity of the cecum this would be considered to be colonic involvement.\n\nUlcerative Colitis (UC)\n\n1\\) Superficial inflammation and\u002For ulceration (involving only the mucosa and submucosa) of the colon which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (N.B. Relative rectal sparing is allowed for patients receiving topical rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).\n\n2\\) In patients with proctitis or left-sided ulcerative colitis there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.\n\n3\\) No inflammation of the small intestine (\"backwash ileitis\" is allowed - non-stricturing superficial inflammation of the terminal ileal mucosa associated with severe pancolitis which resolves following medical or surgical treatment of the colitis).\n\n4\\) No features of Crohn's disease listed above.\n\nInflammatory Bowel Disease Unclassified (IBDU):\n\n1. Confirmed IBD by A, B and C above.\n2. Physician unable to classify individual into either CD or UC based on above criteria and\u002For patient has features of both CD and UC with none of the feature's diagnostic of one or the other.\n\nExclusion Criteria:\n\n* 1\\.\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Inability to provide informed consent.\n2. Non-English speaking\n3. Patients presenting for a one-time consultation.",{"count":170,"type":21},"12 Months","The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.",[119,232,233,27],"Crohn's Disease (CD)","Indeterminate Colitis",[235,226],"Zymfentra","2026-05-22",{"date":238,"type":34},"2026-05-26",{"date":240,"type":34},"2025-11-20",{"date":242,"type":21},"2028-11-03",{"name":244,"class":87},"University of North Carolina, Chapel Hill",9,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":160},"100588705","metabolic-reprogramming-of-monocytes-in-inflammatory-flares-of-inflammatory-bowel-diseases-100588705","NCT06944873","Metabolic Reprogramming of Monocytes in Inflammatory Flares of Inflammatory Bowel Diseases","REPRO-MICI","Inclusion Criteria:\n\n* Men and women over 18\n* Managed at the CHUGA for a severe IBD flare-up requiring hospitalisation or endoscopy for flare-up\n* Patient not objecting to the REPRO-MICI study\n\nExclusion Criteria:\n\n* Patients protected by law (pregnant or breast-feeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalised under duress).\n* Patients with positive HIV, HBV or HCV serology.\n* Patients with a positive ELISPOT with no history of treatment for latent tuberculosis.",{"count":254,"type":21},30,"Inflammatory bowel diseases, Crohn's disease and haemorrhagic rectocolitis, are pathologies that progress in flare-ups, impacting on patients' quality of life and functional or even vital prognosis. These inflammatory diseases require the use of immunosuppressive and immunomodulatory treatments, the side-effects of which can be significant, and the limited number of which sometimes puts patients and practitioners in a therapeutic impasse from which surgery is the only way out. It is therefore important to be able to develop new therapeutic approaches, ideally better tolerated, that can control inflammation during relapses. Monocytes are one of the main players in the inflammatory reaction. In the laboratory, we have developed a strategy for the metabolic reprogramming of these cells based on the use of oxygen microbubbles to modulate the inflammatory response of monocytes.",[27],[258,259],"Monocytes","Metabolic reprogramming","2026-05-18",{"date":262,"type":34},"2026-05-19",{"date":264,"type":21},"2026-07-01",{"date":266,"type":21},"2028-07-31",{"name":268,"class":87},"University Hospital, Grenoble",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100637736","vr-therapies-for-ibd-100637736","NCT07590518","VR Therapies for IBD","AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients With Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility Study","Inclusion Criteria:\n\n* Stated willingness to comply with all study procedures, VR therapy regimen, and availability for the duration of the study\n* Age of 18 years or older\n* Confirmed diagnosis of IBD with concurrent anxiety, defined as a GAD-7 score of ≥10\n* Ability to read and write in English (VR\u002FAI CBT program is currently only available in English)\n* Access to an internet-enabled device (android or iOS smartphone, or personal laptop or desktop computer) to complete surveys and has access to internet and email complete baseline and assessment surveys.\n\nExclusion Criteria:\n\n* Have a condition that interferes with the safe use of VR usage, such as history of seizures, facial injuries precluding headset placement, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions\n* Have cognitive impairments that would affect protocol participation.\n* Currently engaged in psychotherapy (Patients who are taking medications for anxiety or have previously engaged in psychotherapy but are not currently in therapy will remain eligible).\n* Have had an IBD related surgery (including perianal surgery) within the past 6 months or anticipated in the next 6 months\n* Anticipated to change their IBD inflammatory treatment during the study period.",{"count":277,"type":21},76,[143],"Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a AI-enhanced Virtual Reality (VR) Cognitive Behavioral therapy (CBT) program versus distraction VR among patients with inflammatory bowel disease (IBD) and anxiety. It is hypothesized that using VR\u002FAI CBT may reduce anxiety and IBD symptoms, leading to improved overall physical, psychological, and social functioning when compared to distraction VR.",[27,119,120,281],"Anxiety",[283,284],"Virtual Reality","Cognitive Behavioral Therapy","2026-05-12",{"date":287,"type":34},"2026-05-15",{"date":289,"type":21},"2026-06",{"date":291,"type":21},"2027-07",{"name":293,"class":87},"Brennan Spiegel",2,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":160},"100568582","clinical-investigation-of-myibddiet-app-developed-for-inflammatory-bowel-disease-ibd-patients-to-self-manage-their-diet-100568582","NCT06683105","Clinical Investigation of MYIBDDiet App Developed for Inflammatory Bowel Disease (IBD) Patients to Self-manage Their Diet","A Pilot Randomized Trial Investigating the MyIBDDiet App to Improve Self-management of an Anti-inflammatory Diet for Individuals With Inflammatory Bowel Disease","Inclusion Criteria:\n\n1. ≥18 years\n2. Able to provide informed consent\n3. Established diagnosis of IBD determined by treating physician\n4. Not in acute flare\n5. Not pregnant\n6. Willing and able to comply with all required study procedures\n\nExclusion Criteria:\n\n1. Short bowel syndrome\n2. High ostomy output\n3. Intestinal strictures\n4. Pregnancy or breastfeeding\n5. Malnutrition (evaluated by Canadian Nutrition Screening Tool (CNST) )\n6. Conditions requiring dietary restrictions (e.g. Celiac disease, kidney disease, diabetes, eosinophilic esophagitis)\n7. Have other conditions that may require low fibre diet such as irritable bowel syndrome, gastroparesis.\n8. Currently on a therapeutic diet\n9. Already on a diet for IBD or using diet tool for IBD (e.g. Mediterranean or anti-inflammatory diet)\n10. Active malignancy",{"count":303,"type":21},40,[143],"The goal of this clinical trial is to learn if an app designed for diet education can help patients with inflammatory bowel disease (IBD) learn about healthy eating.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is the app easy to use?\n* Is the app useful? Researchers will compare the diet app to see if it is better at teaching patients about a healthy diet than the standard information they may receive from their doctor.\n\nParticipants will be asked to use the app for one month and answer surveys to see how easy the app is to use and if it leads to healthier eating.",[27],[27,308,201,309,310,311,312],"Crohn's disease","Self-management","Malnutrition","Mediterranean diet","Mobile health applications","2026-05-06",{"date":315,"type":34},"2026-05-07",{"date":317,"type":34},"2026-03-15",{"date":319,"type":21},"2029-06-01",{"name":321,"class":87},"University of Alberta",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":344,"leadSponsor":346,"locationsCount":160},"100592130","visualization-of-the-colon-through-use-of-the-magnetic-flexible-endoscope-mfe-in-participants-with-inflammatory-bowel-disease-ibd-100592130","NCT06989424","Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)","Inclusion Criteria:\n\n* Male or female, 18 to 70 years of age\n* Able to provide written informed consent\n* American Society of Anesthesiologists (ASA) class \\\u003C 3\n* No significant medical problems\n* Abdominal circumference \\\u003C 96 cm\n* Stable, non-flaring inflammatory bowel disease (e.g. Ulcerative Colitis and Crohn's Disease)\n\nExclusion Criteria:\n\n* Patients who do not meet inclusion criteria\n* Patients who are unable or unwilling to provide informed consent\n* Magnetic implants and wearable devices (such as insulin pumps)\n* Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.\n* Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.\n* Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough, or anosmia --- or a positive coronavirus (COVID-19) polymerase chain reaction (PCR) swab result\n* Previous incomplete or failed colonoscopy\n* Colonic resection\n* Severe diverticulosis\n* Known or suspected colonic stricture\n* Previous radiation therapy to the abdomen or pelvis\n* Actively flaring inflammatory bowel condition (e.g. active flare of IBD or diverticulitis)\n* Known or suspected bowel obstruction\n* Presence of ascites\n* Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 3 days\n* Known coagulation disorder (INR ≥ 1.5 or platelets \\\u003C 150 x 109)\n* Known to have phenylketonuria or Glucose-6-Phosphate-Dehydrogenase (G6PD) deficiency\n* Abdominal surgery within the last 6 months\n* Drug or alcohol abuse","70 Years",{"count":330,"type":21},6,[143],"In this study, the investigators will test the ability of the Magnetic Flexible Endoscope (MFE) to travel through the colon of people with Inflammatory Bowel Disease (IBD). The MFE is a device made of ultra-flexible tubing that contains a camera, light, and magnet at the tip. The tip of the tube is about the size of a penny. The magnet inside the tip allows the MFE to be moved through the colon by a second magnet attached to a robotic arm that is outside the body. The purpose of this study is to see how the MFE travels through the colon of IBD patients and if it is tolerable.",[27,334],"Colonoscopy",[334,336,337,338,339,27],"Colon","Robotic","Magnetic","Endoscopy","2026-04-19",{"date":342,"type":34},"2026-04-21",{"date":155,"type":21},{"date":345,"type":21},"2027-01",{"name":347,"class":87},"Vanderbilt University Medical Center",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":62,"sex":17,"minAge":18,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":160},"100625466","phase-1-a-phase-1-study-of-pvt401-in-healthy-subjects-100625466","NCT07423000","A Phase 1 Study of PVT401 in Healthy Subjects","A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT401 Following Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Doses in Healthy Subjects","Inclusion Criteria:\n\n1. Healthy male or female, aged between 18 and 65 years, inclusive at Screening.\n2. Body mass index (BMI) of 18.0 to 32.0 kg\u002Fm2, inclusive.\n3. Carry the HLA DRB4\\*0101 or DRB4\\*0103 allele.\n4. Participant is medically healthy (in the opinion of the Investigator), as determined by pre-study medical history and without clinically significant (CS) abnormalities.\n5. Female participants must be of non-child-bearing potential, or, if of child-bearing potential, must have negative pregnancy test, agree not to become pregnant or donate ova, and must agree to use adequate contraception.\n6. Male participants must agree not to donate sperm and use adequate contraception.\n\nExclusion Criteria:\n\n1. Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.\n2. History of hypersensitivity reaction, anaphylaxis or other CS reactions or known allergy to the study drug or its ingredients including but not limited to dextran.\n3. History of any CS disorder which, in the opinion of the Investigator would make implementation of the protocol or interpretation of study results difficult, or that would put the participant at risk by participating in the study.\n4. History of surgery or hospitalisation within 4 weeks prior to Screening, or surgery planned during the study.\n5. Participant has donated blood or blood products or experienced significant blood loss within 2 months prior to the first dose of study drug.\n6. Use of any vaccinations within 4 weeks prior to the first dose of study drug.\n7. Laboratory results at Screening that indicate inadequate renal function, with estimated creatinine clearance of \\\u003C 60 mL\u002Fmin\u002F1.73m2.\n8. Use of any prescription medication within 14 days prior to the first dose of study drug and\u002For over-the-counter medication\u002Fvitamins\u002Fsupplements\u002Fherbal\u002F plant-derived medications within 7 days prior to the first dose of study drug.\n9. Concurrent enrolment in another clinical study, or participation in another clinical study within 30 days or 5 half-lives, whichever is longer, prior to Screening.\n10. Regular consumption of \\> 10 standard alcoholic drinks\u002Fweek. Participant is unwilling to abstain from alcohol while confined to the study clinic.\n11. Positive alcohol breath test at Screening, upon admission to the clinic on Day -1.\n12. Positive urine drugs of abuse test at Screening, upon admission to the clinic on Day -1.\n13. Participant is a heavy smoker, define as more than 2 cigarettes per day or 10 per week.\n14. Participant is unwilling to abstain from smoking while confined to the study clinic.\n15. Participant is breastfeeding\u002Flactating or pregnant, or planning to breastfeed or become pregnant during the study.\n16. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests.\n17. Positive for tuberculosis (TB) disease or latent TB infection.\n18. Ingestion of poppy seed-containing foods or beverages within 48 hours prior to first dose of study drug.","65 Years",{"count":357,"type":21},36,[359],"PHASE1","The goal of this clinical trial is to learn what happens to PVT401 when it enters the human body and how it affects the immune system. It will also provide information about the safety of PVT401 after a single dose and after multiple doses. The main questions it aims to answer are:\n\nWill participants experience any side effects when taking PVT401? How long does it take PVT401 to leave the body after it is administered?\n\nHealthy volunteers will participate in either the single ascending dose (SAD) or multiple ascending dose (MAD) phase.\n\nIn the SAD phase, participants will:\n\nstay in the clinic for two nights, get one dose of PVT401 or a placebo intravenously (through a vein) on Day 1, have blood drawn periodically throughout their stay and be monitored for side effects, and return to the clinic for 3 follow up visits over the four weeks after dosing.\n\nIn the MAD phase, participants will:\n\nstay in the clinic for one night prior to each dose of PVT401 or placebo, and get dosed twice a week for 5 weeks. They will have blood drawn periodically throughout the treatment period and be monitored for side effects, and return to the clinic for 4 follow up visits over the six months after dosing.",[27],[363,364,365,366,367],"Phase 1","First-in-human","Single ascending dose","Multiple ascending dose","Healthy volunteers","2026-04-09",{"date":370,"type":34},"2026-04-13",{"date":372,"type":21},"2026-04",{"date":374,"type":21},"2027-11",{"name":376,"class":41},"Parvus Therapeutics, Inc.",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":391,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":160},"100599844","virtual-versus-dye-based-chromoendoscopy-in-inflammatory-bowel-disease-surveillance-colonoscopy-100599844","NCT07089771","Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy","Inclusion Criteria:\n\n* Age ≥ 18 years and one of the criteria beneath:\n* Extensive ulcerative colitis or indeterminate colitis (IBD-U), or Crohn's colitis involving at least one-third of the colon, with a disease history of at least 8 years\n* IBD or IBD-U with primary sclerosing cholangitis (PSC)\n* IBD or IBD-U with a family history of colorectal cancer in a first-degree relative\n\nExclusion Criteria:\n\n* History of colorectal cancer or prior colectomy\n* Contraindications to dye use\n* Colonoscopies for therapeutic purposes\n* Pregnancy\n* Inability to consent",{"count":384,"type":21},480,[143],"People with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease affecting the colon, have a higher risk of developing colon cancer over time. To catch early signs of cancer, regular colonoscopies are recommended. In this study, the investigators are comparing two advanced methods of examining the colon during these surveillance colonoscopies. One method uses a special dye sprayed inside the colon to highlight abnormal areas (called dye-based chromoendoscopy). The other method uses new technology built into the camera to enhance the view without needing any dye (called virtual chromoendoscopy). Both methods use modern, high-definition equipment.\n\nThe purpose of this study is to find out if the newer, dye-free method is as good as the traditional dye method at detecting pre-cancerous changes (called dysplasia) in people with IBD.\n\nAdults with IBD who are due for a routine surveillance colonoscopy may be invited to take part. Participants will be randomly assigned to one of the two methods. No additional procedures are involved, and only the way the colon is viewed differs. The investigators will also look at how long the procedures take, how many biopsies are needed, any complications, and how patients experience the exam. Participants will be followed over time using national health records to check for long-term outcomes.\n\nThis research will help doctors better understand which method is most effective and comfortable for patients, and may guide future recommendations for cancer screening in people with IBD.",[27,388,389,390],"Ulcerative Colitis (Disorder)","Crohns Disease","Colorectal Neoplasms",[392,393,394,395],"virtual chromoendoscopy","dye-based chromoendoscopy","dysplasia detection","IBD surveillance colonoscopy","2026-03-18",{"date":398,"type":34},"2026-03-20",{"date":400,"type":21},"2026-05-01",{"date":402,"type":21},"2032-12-31",{"name":404,"class":405},"Region Stockholm","OTHER_GOV",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":160},"100629677","phase-2-fecal-microbiota-transplantation-for-primary-sclerosing-cholangitis---randomized-study-versus-sham-transplantation-100629677","NCT07477782","Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation","FMT-SCLER","Inclusion Criteria:\n\n* Males or females\n* Age ≥18 and ≤75 years\n* Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and \u002For extrahepatic biliary duct changes consistent with PSC\n* IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs)\n* IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment)\n* ALP ≥ 1.3 ULN (at least 2 times within a 3 months pre-inclusion period) or elevated total bilirubin ≤50 umol\u002Fl (with concomitant elevated direct bilirubin).\n* Treatment with UDCA (13-23 mg\u002Fkg\u002Fd) for at least 6 months and at the same dosage for at least 3 months\n* Using contraceptive in women of childbearing potential and agrees to pursue it from inclusion until week 48. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly.\n* Written informed consent signed\n* Subject affiliated to the French\n* Social Security System\n\nExclusion Criteria:\n\n* Small duct PSC\n* Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT \\> 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG \\> 1.5 ULN\n* Secondary sclerosing cholangitis (notably IgG4-associated cholangitis)\n* Cirrhosis defined by Liver elastometry \\>14.4 kPa or by current or past decompensation of cirrhosis\n* AST or ALT \\> 7 ULN in the last 3 months\n* Platelets count in the last 3 months \\\u003C 100 000\u002Fmm3\n* Albumin in the last 3 months \\\u003C35g\u002FL\n* Prothrombin index in the last 3 months \\\u003C 70%\n* Hepatic comorbidity: HBV infection (defined by positive Ag HBS), HCV infection (defined by positive HCV RNA), alcohol abuse (defined by alcohol intake \\> 30g\u002Fday), metabolic dysfunction associated steatohepatitis, primary biliary cholangitis, Hemochromatosis, Wilson disease, α1-antitrypsin deficiency, celiac disease\n* History of acute cholangitis in the last 3 months prior to inclusion or current acute cholangitis\n* HIV infection\n* Prior liver transplantation\n* Endoscopic treatment for bile duct stenosis ≤ 3 months prior to inclusion or planned within 3 months post randomization date\n* History of or established or suspected hepatobiliary carcinoma.\n* Any severe comorbidity that may reduce life expectancy\n* History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to inclusion)\n* Dosage changes of treatment for liver disease in the last 3 months or new treatment for liver disease started in the last 3 months\n* History of colorectal carcinoma or high-grade dypsplasia in previous screening colonoscopy\n* History of total colectomy\n* Current active IBD defined by a partial Mayo score \\> 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn's Disease Activity Index (CDAI) \\> 150 in patients with Crohn's disease\n* Changes in IBD treatment or initiation of a new treatment for IBD in the last 3 months\n* Current treatment with biologics (anti-TNF agent, vedolizumab, ustekinumab) or JAK inhibitors (tofacitinnib) or prednisone \\> 10 mg\u002Fday or budesonide \\> 3 mg \u002Fday) (or treatment initiated less than one month)\n* Any contra-indication to swallow capsules\n* Renal insufficiency (clearance\\\u003C60 ml\u002Fmin)\n* Unable to consent, subject to legal or administrative decision (protection measure or deprivation of liberty) or involuntary psychiatric care.\n* Participation in another interventional research without prior consultation with the investigator responsible for the patient's monitoring in the present study (participation in other non-interventional studies is permitted)\n* Pregnancy or desire for pregnancy or breastfeeding\n\nRandomization criteria\n\n* No pregnancy (or desire for in the next year)\n* No other hepatic pathology: HBV (positive HBs Ag), HCV (positive HCV antibody and positive PCR), autoimmune hepatitis\n* No HIV infection (positive serology HIV1+2 antibodies)\n* No documented Clostridium difficile infection at inclusion or \\\u003C 10 days preceding randomization (in case of infection discovered at inclusion)\n* No treatment with antibiotics, antifungics or probiotics \\\u003C 4 weeks.\n* Available FMT with EBV and CMV compatibility",{"count":414,"type":21},72,[24],"Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.",[418,27],"Primary Sclerosing Cholangitis (PSC)",[420,421,422,423,424,425],"Primary Sclerosing Cholangitis","inflammatory bowel disease","fecal microbiota transplantation","ursodeoxycholic acid","alkaline phosphatase","bilirubin","2026-03-12",{"date":428,"type":34},"2026-03-17",{"date":430,"type":21},"2026-05",{"date":432,"type":21},"2030-05",{"name":434,"class":87},"Assistance Publique - Hôpitaux de Paris",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":463},"100601671","phase-2-a-phase-2-study-to-evaluate-therapies-for-inflammatory-bowel-disease-100601671","NCT07113522","A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease","A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics With Multiple Therapies in Participants With Active Crohn's Disease or Active Ulcerative Colitis (ASCEND-IBD)","ASCEND-IBD","Inclusion Criteria-Crohn's Disease:\n\n* Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology\n* Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)\n* Meets drug stabilization requirements\n\nInclusion Criteria-Ulcerative Colitis:\n\n* Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology\n* Moderately to severely active UC as defined by a 3-component MMCS\n* Meets drug stabilization requirements\n\nExclusion Criteria-Crohn's Disease:\n\n* Diagnosis of indeterminate colitis\n* Suspected or diagnosed intra-abdominal or perianal abscess at Screening\n* Previous small bowel resection with combined resected length of \\> 100 cm or previous colonic resection of \\> 2 segments\n* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement\n\nExclusion Criteria-Ulcerative Colitis:\n\n* Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation\n* Current stoma or impending need for colostomy or ileostomy\n* Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase\n* Previous total proctocolectomy or subtotal colectomy","80 Years",{"count":445,"type":21},140,[24],"This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.",[27,119,449],"Crohn's Disease",[451,441,452,453,454,449],"Inflammatory Bowel Diseases","Ulcerative Colitis","UC","CD","2026-03-10",{"date":426,"type":34},{"date":458,"type":34},"2025-06-26",{"date":460,"type":21},"2028-02-04",{"name":462,"class":41},"Mirador Therapeutics, Inc.",66,{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":472,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":160},"100583561","elemental-028-extra-case-studies-100583561","NCT06877923","Elemental 028 Extra Case Studies","Evaluating the Tolerance, Compliance and Acceptability of a Nutritionally Complete Amino Acid-based Nutritional Supplement for the Dietary Management of Conditions With a Severe Impairment of the Gastrointestinal Tract in Children and Adults: a Case Study Series","E028E","Inclusion Criteria:\n\n* Male or female\n* Over 3 years of age\n* Requiring an elemental feed (at least 30% of total energy requirements)\n* Written or electronic informed consent from patient, and\u002For from parent\u002Fcaregiver if applicable\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Requiring parenteral nutrition\n* Major hepatic or renal dysfunction\n* Participation in other studies within 1 month prior to entry of this study\n* Investigator concern around willingness\u002Fability of patient or parent\u002Fcaregiver to comply with protocol requirements","3 Years",{"count":254,"type":21},[143],"Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content micronutrient profile has been developed to better meet the nutritional requirements of patients.\n\nThis series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.",[477,27,478,479,480,481],"Gastrointestinal Disease","Short Bowel","Malabsorption","Allergies","Neurodegenerative Disorders","2026-02-13",{"date":484,"type":34},"2026-02-17",{"date":486,"type":34},"2025-05-01",{"date":488,"type":21},"2027-02",{"name":490,"class":41},"Nutricia UK Ltd",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":245},"100611808","switching-to-the-il-23-inhibitor-guselkumab-for-people-with-active-ibd-who-previously-used-ustekinumab-shift-ibd-100611808","NCT07245394","Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)","SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD","SHIFT-IBD","Inclusion Criteria:\n\n* Subjects of any gender aged ≥ 18.\n* Confirmed diagnosis of IBD (CD, UC, or IBDU) for at least 6 months prior to baseline visit. Subjects with IBDU will be grouped with subjects with UC. The CD proportion of patients will be capped at 75%.\n* Subjects have received ustekinumab for at least 14 weeks and who are currently on or recently discontinued ustekinumab therapy.\n* For subjects that have recently discontinued ustekinumab, the last dose of ustekinumab must have been within 12 weeks before Week 0, and no other advanced therapy (i.e., infliximab, adalimumab, golimumab, certolizumab pegol, vedolizumab, natalizumab, risankizumab, mirikizumab, tofacitinib, upadacitinib, ozanimod, etrasimod) was started since stopping ustekinumab.\n* Subjects with an inadequate response to ustekinumab who require a change in advanced therapy and are initiating guselkumab, as determined by the treating physician.\n* For subjects on off-label ustekinumab dosing (90 mg every 4 or 6 weeks (off-label dosing), enrollment will be capped at 60%.\n* Ability and willingness to give written informed consent and comply with the requirements of this study protocol.\n* Subjects who have evidence of ongoing endoscopic evidence of disease activity within 3 months prior to Week 0, defined as:\n\n  * For Crohn's Disease: Colonoscopy showing SES-CD score (excluding the presence of narrowing component) of ≥6 (or ≥4 for participants with isolated ileal disease), OR presence of ulcers larger than 5 mm in any segment.\n  * For Ulcerative Colitis: Colonoscopy showing Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≥4, OR presence of erosions or ulcers in any segment.\n\nExclusion Criteria:\n\n* History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab).\n* Subjects with formal contraindication to guselkumab per the drug label.\n* Use of guselkumab for an off-label indication, dosing regimen, or route of administration. Subjects who did not receive guselkumab induction will be excluded.\n* Subjects with an ostomy or ileo-anal pouch.\n* Subjects with a history of bowel surgery within 6 months prior to Week 0.\n* Subjects displaying clinical signs of acute severe UC, fulminant colitis or toxic megacolon within 3 months prior to Week 0.\n* Subjects who are expected to require bowel surgery by their IBD physician within the year of enrollment.\n* Subjects on 1 or more concomitant biologics.\n* Subjects with a history of colonic dysplasia (low-grade dysplasia, high-grade dysplasia, or colorectal cancer). Note: Patients with a history of indefinite for dysplasia would be eligible.\n* Subjects with formal contraindication or unwilling to undergo lower endoscopy.\n* The patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.",{"count":170,"type":21},"The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab.\n\nPatients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year.\n\nGuselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care.\n\nResearchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy.\n\nThe goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.",[27,120,119,502],"IBD-unclassified (IBD-U)","2026-02-10",{"date":505,"type":34},"2026-02-12",{"date":507,"type":34},"2026-01-29",{"date":509,"type":21},"2028-11-01",{"name":511,"class":87},"TIDHI Innovation Inc.",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":518,"targetDuration":4,"studyType":22,"phases":520,"briefSummary":521,"conditions":522,"keywords":523,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":294},"100624553","a-pilot-study-on-the-efficacy-and-safety-of-a-novel-synbiotic-formula-sgr11-in-patients-with-inflammatory-bowel-disease-ibd-100624553","NCT07411131","A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)","Inclusion Criteria:\n\n* Individuals aged between 18-75\n* Chinese ethnicity\n* Confirmed diagnosis of ulcerative colitis (UC) with mild to moderate disease activity, defined as a Simple Clinical Colitis Activity Index (SCCAI) of 3-5\n* On stable doses of IBD medication for ≥4 weeks prior to enrolment\n* Ability to provide written informed consent\n* Willingness to comply with study procedures\n\nExclusion Criteria:\n\n* Severe active IBD requiring hospitalization\n* Known history of severe organ failure (including decompensated cirrhosis, malignant disease, kidney failure, epilepsy, active serious infection, acquired immunodeficiency syndrome)\n* Presence of an ileostomy or colostomy\n* Severe comorbidities or immunocompromised states\n* Known current sepsis\n* Recent use of antibiotics, probiotics, or prebiotics within 4 weeks\n* Known pregnancy or breastfeeding\n* Known allergy or intolerance to study components\n* Inability to receive oral fluids\n* Participation in other interventional clinical trials within 30 days",{"count":519,"type":21},50,[143],"The goal of this clinical trial is to find out whether a synbiotic formula (SGR11) can improve symptoms and health measures in people with inflammatory bowel disease (IBD). The main questions it aims to answer are:\n\n* Does SGR11 lead to overall improvement in a participant's condition after 8 weeks, as measured by the Clinical Global Impression-Improvement Scale (CGI I)?\n* Is SGR11 safe and well tolerated in people with IBD?\n\nParticipants will:\n\n* Take the study synbiotic formula (SGR11) daily for 8 weeks\n* Complete symptom and quality of life questionnaires\n* Provide stool samples and, if applicable, blood samples to measure inflammation and gut microbiome changes\n* Report any side effects that occur during the study",[27,119],[122,452,524],"Synbiotic","2026-02-09",{"date":482,"type":34},{"date":528,"type":21},"2026-03",{"date":530,"type":21},"2026-10",{"name":532,"class":87},"Chinese University of Hong Kong",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":62,"sex":17,"minAge":18,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":4},"100623713","diagnosis-of-inflammatory-bowel-disease-100623713","NCT07400211","Diagnosis of Inflammatory Bowel Disease","Non-invasive Molecular Diagnostics for Inflammatory Bowel Disease : A Genetic and Biomarkers Study","Inclusion Criteria:\n\n* Newly histopathologicaly diagnosed IBD\n\nExclusion Criteria:\n\n* Patients with serious complications as intestinal obstruction, perforation, polyps or colorectal carcinoma\n* Patients who are taking NSAIDs or Immunosuppressive drugs\n* Patients who are having other autoimmune disorders\n* Patients with Chronic infections as TB or other diseases\n* Patients with a history of allergy\n* Pregnant or Lactating women","60 Years",{"count":5,"type":21},"* To quantify the expression of Nuclear enriched abundant transcript 1 (NEAT1) and Anti-sense Non RNA in the INLK4 locus (ANRIL) to determine their potential role as non invasive diagnostic biomarkers in inflammatory bowel disease.\n* To evaluate the correlation between the studied biomarkers and both the clinical presentation of the patients and the inflammatory mediators like Nuclear factor κB (NF-KB) signaling pathway.",[27],{"date":545,"type":34},"2026-02-11",{"date":547,"type":21},"2026-04-01",{"date":549,"type":21},"2028-06-01",{"name":551,"class":87},"Assiut University",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":560,"maxAge":443,"enrollmentInfo":561,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":563,"conditions":564,"keywords":567,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":160},"100622554","prophylactic-dexamethasone-before-infliximab-in-moderate-to-severe-ibd-100622554","NCT07385131","Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD","Should Routine Prophylactic Dexamethasone Be Administered Before Intravenous Infliximab in Moderate-to-Severe Inflammatory Bowel Disease: A Prospective, Multicenter, Observational Cohort Study","PA","Inclusion Criteria:\n\n* Aged 14 to 80 years.\n* Confirmed cases of inflammatory bowel disease (IBD) with a definitive diagnosis of Crohn's disease (CD) or ulcerative colitis (UC), based on the diagnostic criteria specified in the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) and the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (Xi'an, 2023). The diagnosis shall be made by comprehensive analysis of clinical manifestations, laboratory tests, imaging examinations, endoscopic examinations and histopathological findings, with infectious colitis and other non-infectious colitis ruled out.\n* Moderate to severe CD: for adults aged 18 years and above, baseline Crohn's Disease Activity Index (CDAI) score \\>220 or Harvey-Bradshaw Index (HBI) score ≥5; for adolescents aged 14 to 17 years, baseline Pediatric Crohn's Disease Activity Index (PCDAI) score ≥31. Or moderate to severe UC: for adults aged 18 years and above, baseline Mayo score ≥6; for adolescents aged 14 to 17 years, baseline Pediatric Ulcerative Colitis Activity Index (PUCAI) score ≥36.\n* Not receiving immunosuppressant therapy (e.g., azathioprine) at present, with no plan to add such medications within the next two months.\n* Current glucocorticoid dosage ≤ 10 tablets, and a definite plan has been made for tapering down the dosage to complete discontinuation within the next two months.\n* Planned to receive the first dose of infliximab within the next two weeks.\n\nExclusion Criteria:\n\n* Patients with severe disease who, as judged by the attending clinician, require biological agent intensification therapy, switch therapy or elective surgery within 2 months, such as those with obvious stenosis, perforation, fistula and other conditions leading to obstruction, hemorrhage, infection, etc.\n* Patients at high risk of infusion reactions, including those with a history of any biological agent-related infusion reactions, or a history of allergy to any drugs such as penicillins, cephalosporins, sulfonamides, non-steroidal anti-inflammatory drugs (NSAIDs), contrast media, etc.\n* Patients with a definite history of food allergy, as well as a past history of asthma or urticaria.\n* Patients on chronic daily use of antihistamine antiallergic drugs such as loratadine, cetirizine, diphenhydramine, chlorpheniramine maleate tablets, terfenadine, etc.\n* Patients with relative contraindications to biological agents, such as active tuberculosis with positive chest X-ray, strongly positive purified protein derivative (PPD) skin test or positive T-SPOT test; a history of myocardial infarction, heart failure or demyelinating neurological diseases in the past 5 years, etc.\n* Patients with relative contraindications to glucocorticoids, such as active tuberculosis, severe infection, gastrointestinal ulcer, etc.\n* Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.\n* Patients complicated with massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, intractable vomiting, severe malabsorption syndrome, etc.\n* Patients with psychiatric disorders or insufficient educational level to fully understand the study content.\n* Pregnant or lactating patients.\n* Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.","14 Years",{"count":562,"type":21},300,"This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel disease (IBD). This study is designed to optimize the prophylactic strategy prior to Infliximab treatment and advocate for risk stratification-based individualized prophylaxis regimens to avoid hormonal abuse. Additionally, it will construct a risk score using biomarkers to accurately identify high-risk populations in need of prophylaxis and establish a corresponding predictive model. The study is also intended to reduce the use of unnecessary medications, shorten infusion duration and alleviate the medical burden. It is expected to provide targeted clinical support during the early stage of the disease or the course of treatment, improve the efficacy and precision of individualized treatment for patients, and reduce the physical, psychological and economic burdens caused by ineffective treatment.",[27,565,566],"CD - Crohn's Disease","UC - Ulcerative Colitis",[568,569,570,571],"Infliximab","Dexamethasone","Preventive medication","Infusion reaction","2026-01-27",{"date":574,"type":34},"2026-02-03",{"date":576,"type":34},"2025-10-08",{"date":578,"type":21},"2029-12-31",{"name":580,"class":87},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":603,"locationsCount":160},"100554729","setting-up-a-cohort-of-patients-with-inflammatory-bowel-disease-and-a-cohort-of-patients-without-chronic-inflammatory-bowel-disease-100554729","NCT06502873","Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease","Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease in the Context of the Translational Study of Biomarkers of Intestinal Dysbiosis (ELITE Walloon Project)","ELITE","Inclusion Criteria:\n\nGeneral criteria:\n\n* Male or female ≥ 18 years old\n* Able to follow the instructions of the study\n* Having signed an informed consent\n\nSpecific for Crohn cohort:\n\n* A confirmed diagnosis of IBD\n* Rectal or colonic or ileocolic involvement\n* Patients with CD presenting inflammatory flare and disease extent in the colon or ileocolic region with:\n* A clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more OR a CDAI (CD Activity Index) ≥ 220 OR a Harvey-Bradshaw Index \\> 8 OR a faecal calprotectin ≥ 250 µg\u002Fg And\n* A endoscopic activity defined by a SES-CD (Simple Endoscopic Score for Crohn Disease) ≥ 6 or a CDEIS (CD Endoscopic Index score) ≥ 7\n* Patients with UC presenting inflammatory flare with:\n\nA clinical activity defined by a modified Mayo score ≥ 3 OR a Simple Clinical Colitis Activity Index ≥5 OR Patient Reported Outcome (PRO2) ≥ 4 with a subscore of rectal bleeding ≥1 OR a faecal calprotectin ≥ 250 µg\u002Fg AND An endoscopic activity defined by a Mayo endoscopic sub-score ≥ 2\n\nSpecific for Control cohort:\n\nPatient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)\n\nExclusion Criteria:\n\nGeneral criteria:\n\n* Commercial Pharmaceutical probiotic administration within the previous month\n* Treatment with antibiotics (whatever the route of administration) within last 3 months\n* Non-remission Cancer or in remission for less than 6 months\n* Any contraindication to colonoscopy and\u002For biopsy, left to PI discretion\n* Under guardianship or judiciable protection\n* Pregnant or breastfeeding women\n* Currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement\n\nSpecific for Crohn cohort:\n\n* Crohn disease localized only in Ileum\n* Inflammatory colon pathology other than Crohn's (infectious, drug-induced,…)",{"count":590,"type":21},120,[143],"The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.",[27],[595,596,597],"cohort","BEV","intestinal dysbiosis",{"date":599,"type":34},"2026-01-28",{"date":601,"type":34},"2024-06-28",{"date":182,"type":21},{"name":604,"class":41},"Artialis",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":62,"sex":17,"minAge":612,"maxAge":4,"enrollmentInfo":613,"targetDuration":615,"studyType":65,"phases":4,"briefSummary":616,"conditions":617,"keywords":660,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":160},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform","2 Years",{"count":614,"type":21},10000,"10 Years","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[618,619,620,621,622,623,624,625,626,627,628,449,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,27,655,656,657,658,659],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Autoimmune Encephalitis","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Autoimmune Diseases","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[637,661,662,663,664,665,666,667,668,669,619,670,671,672,673,674,639,675,676,677,678,679,680,681,682],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":685,"type":34},"2026-01-22",{"date":687,"type":34},"2023-07-05",{"date":689,"type":21},"2030-12-31",{"name":691,"class":87},"Brain Inflammation Collaborative",{"id":693,"slug":694,"hasResults":12,"nctId":695,"briefTitle":696,"officialTitle":697,"acronym":698,"eligibilityCriteria":699,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":700,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":702,"conditions":703,"keywords":706,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":712,"completionDateStruct":714,"leadSponsor":716,"locationsCount":294},"100611238","colorectal-omics-and-ofcs-proteoglycans-coco-in-screening-and-a-diagnostic-pathway-100611238","NCT07237984","Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway","Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans in Screening and Colorectal Cancer Diagnostic Pathway","COCO-S","Inclusion Criteria:\n\n* Patients planned to undergo a colonoscopy either as part of the colorectal cancer screening programme due to a positive FIT or within a 'cancer patient pathway' for CRC at one of the study sites.\n* Able to speak Danish, English, or other languages with sufficient interpretation provided by relatives.\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Patients previously included in the study\n* Patients known to be pregnant (pregnancy test not required)\n* Non-resident in Denmark.",{"count":701,"type":21},2000,"Colorectal Cancer (CRC), or bowel cancer, is a serious disease that affects many people globally. The earlier CRC is diagnosed, the better the patient outcomes.\n\nThe problem with the current diagnostic methods is that they lead to many unnecessary endoscopies (colonoscopies). In Denmark alone, over 30,000 patients every year undergo a colonoscopy without having a serious disease. This puts a major strain on both patients and the healthcare system.\n\nThis research project aims to solve that problem. COCO-S is investigating oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) to see if ofCS can be used as a novel, unique cancer marker found in the blood.\n\nofCS are special molecules that reappear in most tumour tissues. A method has been developed to detect ofCSs in a simple blood sample.\n\nInitial findings from an ongoing study are highly promising. A test using five different ofCS markers has shown very high accuracy in detecting CRC: it correctly identifies 86% of cancer cases (sensitivity) and correctly gives a \"negative\" result in 97% of cases without cancer (specificity).\n\nThe results also suggest that high ofCS levels might help clinicians detect adenomas (polyps), which are early precursors to cancer.\n\nCombining the analysis of ofCS in the blood with the existing stool test (FIT) and other promising blood markers can significantly improve patient selection for a colonoscopy.\n\nThis project will collect blood samples from patients scheduled for a colonoscopy. The blood will be analysed for ofCS and other substances to determine the combined predictive value for patients who truly require the procedure.\n\nThe findings from this project could revolutionize CRC diagnosis. By more accurately identifying patients who need a colonoscopy, the number of unnecessary, invasive procedures can be reduced while maintaining patient safety and ensuring cancer is found in time.",[704,705,27],"Colorectal Cancer","Colorectal Adenoma",[707,704,708,709],"Biomarker","Glycoproteins","Proteomics","2026-01-15",{"date":683,"type":34},{"date":713,"type":21},"2026-03-01",{"date":715,"type":21},"2031-12-31",{"name":717,"class":87},"Nordsjaellands Hospital"]