[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis-uc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis-uc":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,91,0,25,[9,45,75,104,139,162,188,211,236,260,289,313,345,373,396,422,447,468,490,513,534,552,570,592,618],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100642703","prospective-evaluation-of-flare-detection-in-ibd-with-digital-biomarkers-bring-your-own-device-study-100642703",false,"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...","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","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.",[25,26,27],"Inflammatory Bowel Disease (IBD)","Ulcerative Colitis (UC)","Crohn Disease (CD)",[29,30,31],"Inflammatory Bowel Disease","Digital biomarkers","Heart rate variability","NOT_YET_RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":21},"2026-06-15",{"date":40,"type":21},"2027-10-15",{"name":42,"class":43},"Maastricht University Medical Center","OTHER",3,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100644584","online-pain-education-for-crohns-disease-and-ulcerative-colitis-100644584","NCT07671313","Online Pain Education for Crohn's Disease and Ulcerative Colitis","Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Physician-confirmed diagnosis of Crohn's disease or ulcerative colitis\n* Chronic pain (visceral and\u002For somatic) related to IBD for at least 3 months\n* NIH PROMIS Pain Interference scale T-score ≥60\n* Medically stable, defined as:\n\n  1. No acute IBD-related hospitalization within the past 3 months; AND\n  2. No planned IBD surgery or planned therapeutic escalation within the next 2 months, including initiation of a new advanced therapy, dose escalation or switch of advanced therapy, or corticosteroid taper\n* Able to understand and complete questionnaires independently in English\n* Access to an internet-enabled device for online surveys and intervention access.\n\nExclusion Criteria:\n\n* Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation\n* Current use of standing opioid medications, given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia\n* Prior participation in cognitive behavioral therapy (CBT) specifically targeting chronic IBD-related pain",{"count":53,"type":21},60,"INTERVENTIONAL",[56],"NA","Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online pain educations programs among adult patients with inflammatory bowel disease (IBD) who experience chronic pain. Each online program can be accessed on the patient's personal device, and will take about 2 hours to complete. Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8-weeks post-treatment.",[59,26,60],"Crohn's Disease","Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)",[62,63,64],"Pain Education","Remote Monitoring","Chronic pain","2026-06-22",{"date":67,"type":36},"2026-06-26",{"date":69,"type":21},"2026-08",{"date":71,"type":21},"2027-09",{"name":73,"class":43},"Cedars-Sinai Medical Center",1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":54,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100624854","phase-2-ly4268989-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100624854","NCT07415044","LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis","A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)","EMERALD-3","Inclusion Criteria:\n\n* Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC\n* Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1\n* Have evidence of UC extending proximal to the rectum\n* Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded\n* Must meet contraception requirements\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies\n* Have a diagnosis or history of malignant disease within 5 years prior to randomization","80 Years",{"count":85,"type":21},1431,[87],"PHASE2","The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.\n\nThe study will last up to approximately 108 weeks, excluding screening.",[26,90,91],"Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe","RECRUITING","2026-06-19",{"date":95,"type":36},"2026-06-23",{"date":97,"type":36},"2026-03-26",{"date":99,"type":21},"2031-07",{"name":101,"class":102},"Eli Lilly and Company","INDUSTRY",253,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100644418","cardiovascular-risk-in-patients-with-ibd-100644418","NCT07663201","Cardiovascular Risk in Patients With IBD","Dissecting the Complexity of Inflammatory Bowel Disease (IBD) A Prospective Study With Focus on Cardiovascular Risk","DICOM-IBD","Inclusion Criteria:\n\nEstablished diagnosis of ulcerative colitis and Crohn's disease\n\nExclusion Criteria:\n\nAge \\> 18 years Not compliant with study protocol",true,{"count":114,"type":21},300,"In this study our Research Hospital San Donato Policlinic ask your partipation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease. Multiple parameters (therapy, disease activity, life style) and investigations (DNA, stool, lab tests) will be evaluate with the support of artificial intelligence methodologies to better define the cardiovascular risk.",[26,117,118],"Crohn's Diseases","Cardiovascular Risk",[120,121,122,123,124,125,126,127,128,129,130],"Ulcerative colitis","Crohn's disease","Inflammatory bowel disease","Cardiovascular risk","Stroke","Cardiovascular death","Myocardial infarction","Atrial fibrillation","Ischemic heart disease","Major cardiovascular events","Acute Arterial events (i.e. pulmonary embolism)","2026-06-17",{"date":95,"type":36},{"date":134,"type":21},"2026-09",{"date":136,"type":21},"2029-12",{"name":138,"class":43},"IRCCS Policlinico S. Donato",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":54,"phases":148,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":74},"100641649","palmitoylethanolamide-in-ulcerative-colitis-100641649","NCT07609810","Palmitoylethanolamide in Ulcerative Colitis","The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients","Inclusion Criteria:\n\n* Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.\n* Active mild-to-moderate UC patients defined by a SCCAI score ≥ 5 and \\\u003C 12 at screening, not responding to 5-aminosalicylates (5-ASA) defined as persistent rectal bleeding beyond 2 weeks or failure to achieve sustained symptom relief after 40 days of appropriate 5-ASA therapy, steroid-dependent defined as unable to reduce steroids below the equivalent of prednisolone 10 mg\u002Fday or budesonide below 3 mg\u002Fday within 3 months of starting steroids, without recurrent active disease or who have a relapse within 3 months of stopping steroids and they currently take azathioprine.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Alcohol or drug abuse.\n* Allergy or known hypersensitivity to palmitoylethanolamide.\n* Active infection (enteric or systemic).\n* Uncontrolled metabolic\u002F neurologic conditions: uncontrolled hypertension, uncontrolled diabetes, migraine disorders or other uncontrolled neurologic disease.\n* Other autoimmune diseases.\n* Severe or acute severe colitis requiring hospitalization.\n* UC patients requiring colectomy.\n* Crohn disease (CD), chronic pancreatitis, cholecystitis or other inflammatory conditions involving the gastrointestinal tract (GIT).\n* Patients with renal or liver disease.\n* Patients who have never been treated for UC.\n* Any patients on biologics.\n* Patients using NSAIDs or aspirin (due to interference with fecal calprotectin results).","65 Years",{"count":53,"type":21},[56],"Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.",[26],[152],"palmitoylethanolamide - endocannabinoid - disease activity","2026-06-12",{"date":155,"type":36},"2026-06-16",{"date":157,"type":21},"2026-07-15",{"date":159,"type":21},"2029-02-15",{"name":161,"class":43},"Ain Shams University",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":171,"studyType":22,"phases":4,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":74},"100643044","individualizing-anti-tnf-therapy-in-patients-with-inflammatory-bowel-disease-100643044","NCT07644117","Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease","Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease: Pre-Treatment Prediction of Immunogenicity and Response. A Prospective Observational Study.","Inclusion Criteria:\n\n* Established IBD: Crohn's disease (CD) or ulcerative colitis (UC)\n* Anti-TNF naïve\n* Clinically active disease (HBI\\>5 for CD, p-MS≥ 3 for UC)\n* Elevated inflammatory indices CRP\\>10 or fecal calprotectin\\>250\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Anti-TNF experienced\n* Unable to complete the study protocol",{"count":170,"type":21},40,"52 Weeks","This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy.\n\nParticipants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.",[174,27,26],"IBD (Inflammatory Bowel Disease)",[176,177,178],"IBD","Anti-TNF","Response to treatment","2026-06-11",{"date":153,"type":36},{"date":182,"type":36},"2025-01-04",{"date":184,"type":21},"2028-12",{"name":186,"class":187},"Shmuel Kivity, MD","OTHER_GOV",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":195,"targetDuration":4,"studyType":54,"phases":197,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100642782","phase-3-hemay005-for-the-treatment-of-chinese-moderately-to-severely-active-ulcerative-colitis-100642782","NCT07650942","Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Re-randomized Study To Assess the Efficacy and Safety With Hemay005 Tablets in Chinese Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Men or women 18 to 80 years of age, inclusive, at the time of consent.\n2. Voluntarily to give written informed consent.\n3. Diagnosed with UC established at least 3 months prior to screen visit. The diagnosis must be confirmed by clinical and endoscopic evidence, corroborated by a histopathology report.\n4. Active UC confirmed by endoscopy, classified as Montreal E2 or E3.\n5. Moderately to severely active UC, defined as mMS of 5 to 9 points, including a MES of at least 2 (confirmed through centrally read endoscopy) and a SFS of at least 1 and a RBS of at least 1. The endoscopy should be performed within 14 days prior to randomization.\n6. Demonstrated inadequate response, loss of response and\u002For intolerance to at least one of the following UC therapies:\n\n   A) Conventional therapies, including oral 5-aminosalicylic acid (5-ASA) compounds, corticosteroids, immunoregulatory agents.\n\n   B) Advanced therapies: biologics (including but not limit to antitumor necrosis factor alpha (TNFα) antibodies, anti-integrin antibodies, anti-interleukin 12\u002F23 antibodies) and small molecule therapies(including but not limit to JAK inhibitors, S1P receptor modulators) Note: The medication used to qualify the subject for entry into this category must be approved for the treatment of UC in the country of use and the subject must have received an adequate course of therapy based on local guidelines for that therapy.\n7. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception and agreement to refrain from egg donation or undergo fertility treatment during the treatment period and for 30 days after the final dose of Hemay005. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 30 days after the final dose of Hemay005.\n\nExclusion Criteria:\n\n1. Current diagnosis of CD, abdominal\u002Fintrabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.\n2. Severe UC as evidenced by any of the following:\n\n   A) Hospitalization for the treatment of UC ≤ 2 weeks prior to screening or, in the physician's judgement, is likely to require hospitalization for medical care or surgical intervention of any kind for UC during the study.\n\n   B）Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months) of toxic megacolon, or bowel perforation.\n\n   C）Prior history of subtotal, or total colectomy.\n3. Past or current evidence of any gastrointestinal malignancy, either prior to or at the time of screening. History of malignancy within 5 years prior to screening visit, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer.\n4. Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.\n5. Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, ), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise patient safety, interfere with the potential participant's provision of informed consent, or compliance with trial procedures.\n6. Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV).\n7. Evidence of active tuberculosis (TB).\n8. Any condition that would preclude endoscopic evaluation.\n9. Either received protocol-specified prohibited medicines prior to baseline endoscopy and\u002F or randomization, or have not be washed out sufficiently due to the protocol before baseline endoscopy and\u002F or randomization.",{"count":196,"type":21},360,[198],"PHASE3","The purpose of this phase III, multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Hemay005 compared to placebo as induction and maintenance therapy in Chinese participants with moderately to severely active ulcerative colitis.",[26],[29],"2026-06-10",{"date":155,"type":36},{"date":205,"type":21},"2026-06",{"date":207,"type":21},"2029-02",{"name":209,"class":102},"Ganzhou Hemay Pharmaceutical Co., Ltd",2,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":54,"phases":221,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100563732","phase-1-study-of-xmab942-in-healthy-participants-and-participants-with-ulcerative-colitis-100563732","NCT06619990","Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants With Moderate-To-Severe Active Ulcerative Colitis.","Inclusion Criteria:\n\nParts A and B\n\n* Age 18-55\n* Must be in good health with no significant medical history\n* Clinical laboratory values within normal range\n* BMI 18-35 (inclusive)\n* Contraceptive use by men or women consistent with local regulations\n* Able and willing to provide written informed consent\n\nPart C\n\n* Age 18-75\n* Must be in good health with no significant medical history\n* UC diagnosis ≥ 3 months prior to screening\n* Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1\n* Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy\n* Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies of UC\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\nParts A and B\n\n* Any physical or psychological condition that prohibits study completion\n* History of suicidal behavior or suicidal ideation\n* Heavy use of nicotine containing products\n* HIV, hepatitis B and hepatitis C positive\n* Cardiac arrhythmia, or clinically significant abnormal ECG\n* Active use of prescription medications within 14 days of Day -1\n* Active use of over-the-counter, or herbal medication within 7 days of Screening\n* Other investigational products within 30 days\n* Blood or plasma donation within 60 days\n* Pregnant or breastfeeding\n\nPart C\n\n* Any physical or psychological condition that prohibits study participation\n* Diagnosis of Crohn disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.\n* Positive screen for Clostridium difficile (C. Difficile) toxins\n* HIV, hepatitis B and hepatitis C positive\n* Cardiac arrhythmia, or clinically significant abnormal ECG\n* Pregnant or breastfeeding\n\nOther protocol defined inclusion\u002Fexclusion criteria apply.","75 Years",{"count":220,"type":21},270,[222,87],"PHASE1","Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).",[26],[226,29,227],"Ulcerative Colitis","Healthy Volunteers",{"date":179,"type":36},{"date":230,"type":36},"2024-10-10",{"date":232,"type":21},"2029-01",{"name":234,"class":102},"Xencor, Inc.",66,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":74},"100643066","urinary-pge-mum-as-a-marker-for-ulcerative-colitis-activity-100643066","NCT07637045","Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity","Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt","PGE-MUM_UC","Inclusion Criteria:\n\n* Adult patients aged ≥18 years\n* Confirmed diagnosis of Ulcerative Colitis based on clinical, endoscopic, and histopathological criteria\n* Active disease (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4) OR remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients with other types of colitis (e.g., Crohn's disease, infectious colitis, ischemic colitis)\n* History of colectomy\n* Current smokers\n* Chronic lung disease\n* Malignancy\n* Use of laxatives or NSAIDs within 2 weeks prior to enrollment\n* Chronic kidney disease\n* Pregnancy or lactation\n* Active infection",{"count":245,"type":21},114,"Ulcerative colitis (UC) is a chronic inflammatory bowel disease that requires regular monitoring of disease activity. Currently, assessment depends on invasive colonoscopy or clinical scores that may not accurately reflect intestinal inflammation. This study aims to evaluate whether urinary Prostaglandin E-Major Metabolite (PGE-MUM) can serve as a non-invasive biomarker to discriminate disease activity in patients with ulcerative colitis.\n\nThis cross-sectional study will be conducted at Al-Rajhi University Hospital, Assiut University, Egypt.This study plans to enroll 114 adult patients (≥18 years) with confirmed UC diagnosis, divided into two equal groups: active disease and remission (57 patients each). Disease activity will be assessed using the Mayo Endoscopic Score (MES) and Clinical Activity Index (CAI). Urine samples will be collected from all participants to measure PGE-MUM levels. Blood samples will be tested for CRP, CBC, albumin, and creatinine. Colonoscopy with biopsy will be performed for endoscopic scoring and histopathological assessment using Geboes score.\n\nThe primary outcome is to establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with UC. Secondary outcomes include comparing PGE-MUM with CRP, determining the optimal cut-off value, and correlating PGE-MUM levels with MES and Geboes score.\n\nIf successful, urinary PGE-MUM could provide a simple, non-invasive, and cost-effective method for monitoring UC activity in the Egyptian healthcare setting, reducing the need for frequent colonoscopies and overcoming cultural barriers associated with stool collection.",[26],[226,249,250,29,251],"PGE-MUM","Urinary biomarker","Non-invasive biomarker","2026-06-09",{"date":179,"type":36},{"date":255,"type":21},"2026-08-01",{"date":257,"type":21},"2027-06-30",{"name":259,"class":43},"Assiut University",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":268,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":54,"phases":272,"briefSummary":273,"conditions":274,"keywords":277,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":285,"leadSponsor":287,"locationsCount":74},"100642387","phase-2-vancomycin-efficacy-in-response-to-dysbiosis-in-atypical-colitis-100642387","NCT07646223","Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis","The Efficacy of Oral Vancomycin Therapy in Managing Different Phenotypes of Paediatric Inflammatory Bowel Diseases by Correlating Treatment Response to Commensal Microbiota Composition and Function","VERDA","Inclusion criteria.\n\n* children aged 6-15 years\n* able to swallow capsules\n* are scheduled for diagnostic endoscopy at Tampere University\n* has not received oral vancomycin before\n* do not have active infection (such as clostridium or other bacteria)\n* has not received new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT.\n\nExclusion Criteria:\n\n* The presence of PSC without UC, Crohn's disease type of inflammatory bowel diseases.\n* Under the age of 6 years old.\n* Is unable to swallow capsules.\n* Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and\u002For other related antibiotics similar to vancomycin.\n* Presence of malignant disease or potential need for liver transplantation within the following 12 months.\n* Pregnancy\n* Known renal insufficiency or chronic renal disease","6 Years","15 Years",{"count":271,"type":21},140,[87],"The goal of this clinical trial is to learn how oral vancomycin therapy may contribute in treating paediatric inflammatory bowel disease, particularly atypical ulcerative colitis and PSC-associated colitis. It will also give more information on how this treatment affects gut microbiota and metabolism.\n\nThe main questions it aims to answer are:\n\n1. Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)?\n2. How does oral vancomycin change gut metabolism?\n3. Does different types of colitis respond differently to oral vancomycin?\n\nResearchers will compare children receiving oral vancomycin plus standard therapy to those receiving standard therapy alone. The gut metabolisim before and after oral vancmycin will also be compared, as well as to healthy controls and children with typical ulcerative colitis.\n\nParticipants will:\n\n1. Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response\n2. Visit the clinic approximately every 3 months for checkups, tests, and monitoring\n3. Provide blood, stool, and saliva samples to study disease activity and microbiota activity\n4. Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy\n5. Complete questionnaires about quality of life\n6. Be monitored for side effects and treatment response throughout the study period",[26,275,276],"Primary Sclerosing Cholangitis (PSC)","Pediatric Inflammatory Bowel Diseases",[278,279,280,281,282],"PSC-UC","atypical UC","oral vancomycin","colitis","PIBD",{"date":153,"type":36},{"date":255,"type":21},{"date":286,"type":21},"2035-12-31",{"name":288,"class":43},"Tampere University Hospital",{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":297,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":54,"phases":301,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":74},"100642951","using-breath-tests-to-study-gut-sulfur-changes-during-dietary-therapy-100642951","NCT07640659","Using Breath Tests to Study Gut Sulfur Changes During Dietary Therapy","Sulfur on the Breath: Using Breath Biomarkers to Monitor Gut Microbial Sulfur Metabolism During Elemental and Reduced Sulfur Dietary Therapy","Sulfur-UC","Inclusion Criteria:\n\n* Age 19-70 years.\n\n  =Diagnosis of mild-to-moderate ulcerative colitis, defined by a partial Mayo score (pMayo) of 2-7.\n* Evidence of active inflammation at enrollment, defined as:\n* C-reactive protein (CRP) \\> 5 mg\u002FL; or\n* Fecal calprotectin (FCP) \\> 200 µg\u002Fg.\n* Receiving stable medical therapy for ulcerative colitis for at least 8 weeks prior to enrollment.\n* No corticosteroid use at the time of recruitment.\n* Under consideration by the treating physician for treatment escalation or biologic switch due to inadequate response to current therapy.\n\nExclusion Criteria:\n\n* Partial Mayo score (pMayo) \\> 7.\n* Pregnant or breastfeeding.\n* Body mass index (BMI) \\\u003C 18 kg\u002Fm².\n* History of an eating disorder.\n* Severe psychiatric disorder.\n* Severe medical conditions, including:\n* Active cancer;\n* Significant cardiovascular disease;\n* Diabetes mellitus; or\n* Severe food allergies.\n* Known allergy or intolerance to corn, dextrose, or maltodextrin.\n* Antibiotic use within 3 months prior to enrollment.\n* Probiotic use within 3 months prior to enrollment.\n* Use of herbal anti-inflammatory supplements during the study period, including but not limited to:\n* Serrapeptidase;\n* Curcumin;\n* Boswellia; or\n* Bromelain.\n* History of major gastrointestinal surgery, including:\n* Ostomy;\n* Total colectomy; or\n* Short bowel syndrome.\n* Inability or unwillingness to comply with study procedures, including anticipated travel or other commitments that may interfere with participation.","19 Years","70 Years",{"count":300,"type":21},45,[56],"This study aims to test whether a short liquid-based diet, followed by a low-sulfur eating plan, is safe, manageable, and helpful for people with mild to moderate ulcerative colitis. Investigators want to see if this approach can improve gut health, lower inflammation, and reduce symptoms. Investigators will also test breath samples as an easy, non-invasive way to track gut bacteria activity and disease changes. Investigators believe this diet plan can reduce harmful gut bacteria that produce irritating sulfur compounds, leading to better gut health and measurable improvements that can be detected through breath testing.",[26],[120],"2026-06-05",{"date":179,"type":36},{"date":308,"type":21},"2026-06-01",{"date":310,"type":21},"2029-12-31",{"name":312,"class":43},"University of British Columbia",{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":321,"targetDuration":4,"studyType":54,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":341,"leadSponsor":343,"locationsCount":74},"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.",{"count":322,"type":21},162,[56],"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.",[26,25,326],"Colitis",[120,122,328,329,330,331,332,333,334,335,336,337,338],"Microbiome","Gut microbiota","Fecal calprotectin","Artificial intelligence","Partial Mayo score","5-ASA","Mesalamine","Nutraceutical","Placebo-controlled trial","Blastocystis","Microbiome-targeting nutraceutical",{"date":252,"type":36},{"date":202,"type":21},{"date":342,"type":21},"2027-11-30",{"name":344,"class":102},"ENBIOSIS BIOTECHNOLOGIES",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":54,"phases":355,"briefSummary":356,"conditions":357,"keywords":361,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":74},"100643065","phase-1-a-phase-i-study-to-evaluate-the-safetytolerability-of-bdhk-2009-tablets-in-healthy-adult-100643065","NCT07632573","A Phase I Study to Evaluate the Safety\u002FTolerability of BDHK-2009 Tablets in Healthy Adult","A Phase I Clinical Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics\u002FPharmacodynamics of BDHK-2009 Tablets in Healthy Adult Participants: a Randomized, Double-blind, Placebo-controlled, Single-dose\u002FMultiple-dose Escalation Study.","Inclusion Criteria:\n\n\\- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily participate in the trial, and understand and sign the informed consent form.\n\n2\\. Healthy participants aged 18 to 55 years (inclusive), regardless of gender. 3. Weight ≥ 50 kg (for males) and ≥ 45 kg (for females), with a body mass index (BMI) of 18-26 kg\u002Fm².\n\n4\\. At screening, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, serological virology, thyroid function, etc.) results are either within normal limits or, if abnormal, not clinically significant.\n\n5\\. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening and baseline, and must not be pregnant, lactating, or planning pregnancy during the study period. WOCBP must agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product (whichever is longer).\n\n1. WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;\n2. Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery. Postmenopausal is defined as the absence of menstruation for ≥ 12 months without alternative medical intervention. Follicle-stimulating hormone (FSH) testing will be performed for subjects with uncertain status, and FSH \\> 40 mIU\u002FmL can confirm menopause.\n\n   6\\. Male participants with partners of childbearing potential are eligible for the study only if they agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product, and agree not to donate sperm during this period. In addition, male participants with partners of childbearing potential must use condoms continuously until at least 90 days after the last dose of the investigational product (whichever is longer).\n\n   Exclusion Criteria:\n   * 1\\. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the participant's participation in the study, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder.\n\n     2\\. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, psychiatric, thyroid, or other disorders, as determined by the investigator to be unsuitable for participation in this study.\n\n     3\\. Presence or suspected presence of active viral, bacterial, fungal, or parasitic infection.\n\n     4\\. History of recurrent or chronic infections.\n\n     5\\. Participants with acute illness within 2 weeks prior to screening; participants with clinically significant infections (e.g., upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; participants with evidence of any infection within 7 days prior to screening; participants with a history of herpes simplex infection or recurrent (\\>1 episode) herpes zoster or disseminated herpes zoster.\n\n     6\\. History of epidemic meningococcal infection.\n\n     7\\. History of splenectomy or functional asplenia.\n\n     8\\. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody.\n\n     9\\. Participants with a history of active tuberculosis or evidence of active or latent tuberculosis infection at screening.\n\n     10\\. Participants with a history of allergic tendencies, such as asthma, atopic dermatitis, chronic urticaria, or allergic rhinitis, or with allergies to two or more medications, foods, or pollens; participants with a history of hypersensitivity to the investigational drug or any of its components or to drugs with the same mechanism of action, or with clinically significant allergy history as determined by the investigator to be ineligible for enrollment.\n\n     11\\. Participants who have participated in another interventional clinical study and received an interventional treatment (including investigational drugs and investigational medical devices) within 30 days prior to the first dose of the study drug, or within 5 half-lives of the study drug (whichever is longer).\n\n     12\\. Participants with a history of drug abuse within 12 months prior to screening, or participants with positive urine drug screening results.\n\n     13\\. Participants who have used any strong inducers or strong inhibitors of the hepatic metabolic enzyme CYP3A within 14 days or 5 half-lives prior to administration of the investigational drug (whichever is longer).\n\n     14\\. Participants who have used any prescription medications within 14 days prior to administration of the investigational drug, or any over-the-counter medications, herbal medicines, or dietary supplements within 7 days prior to administration of the investigational drug, unless the investigator determines that the medication is not clinically significant.\n\n     15\\. Participants who have consumed any foods or beverages containing substances that may induce or inhibit hepatic metabolic enzymes (such as grapefruit, Seville orange, or star fruit, etc.) within 7 days prior to administration of the investigational drug, or who are unable to avoid consumption of foods or beverages containing caffeine within 48 hours prior to administration of the investigational drug and throughout the inpatient study period.\n\n     16\\. Participants who consumed more than 14 units of alcohol per week within 1 month prior to screening (1 unit of alcohol is approximately equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), or who consumed any alcohol products within 24 hours prior to dosing, or who have positive alcohol screening test results.\n\n     17\\. Heavy smokers or participants who smoked more than 5 cigarettes per day within 3 months prior to dosing, and who are unable to abstain from using more than 5 tobacco or nicotine-containing products (including nicotine patches) per week from screening through the end of the study.\n\n     18\\. Participants who donated blood or experienced blood loss ≥ 200 mL within 1 month prior to screening or dosing, or who donated blood or experienced blood loss ≥ 400 mL within 3 months prior to dosing, or who have difficult venous access or are unable to tolerate blood sampling.\n\n     19\\. At screening or baseline, 12-lead electrocardiogram (ECG) findings showing clinically significant abnormalities, including but not limited to: QTcF \\> 450 ms, or other arrhythmias or morphological abnormalities as determined by the investigator that may increase participant risk or interfere with data interpretation.\n\n     20\\. Participants with dysphagia or special dietary requirements who are unable to accept a standardized diet (e.g., severe food allergies).\n\n     21\\. Participants who have undergone major surgical procedures within 3 months prior to screening or who are planning to undergo surgery during the trial period.\n\n     22\\. Participants who have received vaccination within 8 weeks prior to screening, or who plan to receive vaccination during the study or within 8 weeks after administration of the study drug.\n\n     23\\. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.","55 Years",{"count":354,"type":21},68,[222],"A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.",[26,358,359,174,360],"Ulcerative Colitis (Disorder)","Ulcerative Colitis Acute","CD - Crohn's Disease",[121,226,29,176,362,363],"CD","UC","2026-06-02",{"date":366,"type":36},"2026-06-08",{"date":368,"type":36},"2026-05-18",{"date":370,"type":21},"2027-02-28",{"name":372,"class":102},"Benethera (Shaoxing) Biotechnology Co., Ltd.",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":381,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":74},"100640283","leucine-rich-2-glycoprotein-correlation-with-clinical-endoscopic-and-histological-disease-activity-of-ibd-in-a-european-context-100640283","NCT07621783","Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context","Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context: LEADER Trial.","LEADER","Inclusion Criteria:\n\n1. ≥18 years\n2. Patient with confirmed diagnosis of IBD\n3. Patient with planned endoscopy (ileocolonoscopy for Crohn's disease (CD)\u002Fulcerative colitis (UC) or sigmoidoscopy for UC) for the assessment of endoscopic disease activity according to routine practice\n4. willing to provide informed consent\n\nExclusion Criteria:\n\n1. Patient with IBD unspecified\n2. Patient with ileo- or colostomy\n3. Patient with total colectomy\n4. Women that are pregnant","16 Years",{"count":383,"type":21},100,"Prospectively study the correlation between Leucine-rich α2-glycoprotein (LRG) and clinical\u002Fendoscopic\u002Fhistological disease activity in patients with inflammatory bowel disease (IBD) in Europe.",[27,26],[387],"Crohn; ulcerative colitis, LRG, endoscopic remission, endoscopic activity, PRO, quality of life","2026-05-29",{"date":364,"type":36},{"date":391,"type":36},"2026-05-01",{"date":393,"type":21},"2026-12-31",{"name":395,"class":43},"Imelda GI Clinical Research Center",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":405,"studyType":22,"phases":4,"briefSummary":406,"conditions":407,"keywords":410,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"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":404,"type":21},200,"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.",[26,408,409,25],"Crohn's Disease (CD)","Indeterminate Colitis",[411,401],"Zymfentra","2026-05-22",{"date":414,"type":36},"2026-05-26",{"date":416,"type":36},"2025-11-20",{"date":418,"type":21},"2028-11-03",{"name":420,"class":43},"University of North Carolina, Chapel Hill",9,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":54,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":74},"100625775","phase-2-selenium-supplementation-in-moderate-severely-active-ulcerative-colitis-patients-treated-with-advanced-therapies-100625775","NCT07427017","Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies","Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies: A Placebo-Controlled, Double-Blind, Randomized Clinical Trial","Selenium-UC","Inclusion Criteria:\n\n* Known or newly diagnosed moderate to severe UC (as defined by the modified Mayo score of 5-9; confirmed by clinical, endoscopic, and\u002For histopathological evidence prior to screening as per standard of care) who are either being started on or are being switched to a different FDA approved advanced therapy\n* The acceptable list of advanced therapies is (anti-TNF, anti-IL23, anti-integrin). For example, anti-tumor necrosis factor - infliximab, adalimumab, golimumab, certolizumab; anti-IL12\u002F23 - ustekinumab, mirikizumab, risakizumab, guselkumab; anti-integrin - vedolizumab\n\n  * Mayo endoscopic sub-score ≥2 (moderate to severe)\n  * Mayo rectal bleeding sub-score ≥1 (moderate to severe)\n  * Mayo stool frequency sub-score ≥2 (moderate to severe)\n* Age 18-85 and able to fully participate in all aspects of the trial\n\nExclusion Criteria:\n\n* Pediatric patients defined by being younger than 18 years of age\n* Patients who are currently pregnant, expecting to participate in getting pregnant during the study period through natural or assisted techniques (in-vitro fertilization, intra-uterine insemination, intracytoplasmic sperm injection, embryo transfer, planned egg or sperm donor), or are currently lactating.\n\n  * Women with childbearing potential will be required to use highly effective birth control if not surgically sterile or postmenopausal for ≥ 2 years for the duration of the active intervention period. Highly effective forms of birth control include those that alone or in combination result in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly. This would include combined pill and progestin-only pill, evra patch, nuvaring, depo-provera, paragard, mirena, implanon, female sterilization, male sterilization.\n  * The criteria for being considered postmenopausal would be the following: twelve months of spontaneous amenorrhea or; six months of spontaneous amenorrhea with serum FSH levels 40 mIU\u002FmL or; six weeks post-surgical bilateral oophorectomy with or without hysterectomy.\n  * Male subjects are considered of reproductive potential unless surgically sterile (e.g., vasectomy) and should not participate in activities of reproductive potential other than heterosexual intercourse (e.g., they should not participate in in-vitro fertilization or other reproductive assistance techniques) during the active intervention period of 12 weeks. Male subjects of reproductive potential that have female partners of reproductive potential should commit to the use of recommended contraception in the partnership during the active intervention period of 12 weeks, and be informed of the recommendations for pregnancy screening during the intervention phase of the trial. Additionally, male subjects (regardless of reproductive potential) that have partners that are currently pregnant should commit to condom use during intercourse to prevent transmission of the drug product through semen during the active intervention period of 12 weeks.\n* If participants become pregnant during the intervention period, they will be withdrawn to avoid risks to the fetus. If participants become pregnant during the follow-up observational period, they will be permitted to remain in the study as no active intervention is being administered. Research related assessments and visits will be tailored to those recommended during pregnancy by the treating provider(s).\n* Medical conditions that may predispose to toxicity including a history of type 2 diabetes mellitus, hypothyroidism, acute or chronic kidney disease, history of kidney transplant, history of infertility.\n* Abnormal baseline labs for renal function, thyroid function, or hepatic function: Renal function panel including creatinine (results should fall within normal lab reference ranges below 1.3 mg\u002FdL for males and 1.1 mg\u002FdL for females). Thyroid function tests with thyroid stimulating hormone (TSH; results should fall within normal lab reference ranges of 0.5 to 5.0 mIU\u002FL). Hepatic function panel (results should fall within normal lab reference ranges) including alanine aminotransaminase (below 55 U\u002FL for males and 45 U\u002FL for females), aspartate aminotransferase (below 40 U\u002FL for males and 32 U\u002FL for females), total bilirubin (below 1.2 mg\u002FdL), direct bilirubin (below 0.3 mg\u002FdL), alkaline phosphatase (below 120 IU\u002FL for males and 104 IU\u002FL for females).\n* Any patient taking blood thinners, cholesterol-lowering drugs, antioxidants, warfarin, or any other immune system-dependent medications that may interact with selenium. Specifically, they should not be taking any of the following: alendronate, baloxavir marboxil, cinoxacin, ciprofloxacin, deferiprone, delafloxacin, dimercaprol, eltrombopag, enoxacin, etidronate, gatifloxacinm gemifloxacin, grepafloxacin, ibandronate, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, patiromer, penicillamine, risedronate. sodium polystyrene sulfonate, sparfloxacin. tiludronate, trientine, trovafloxacin, vadadustat\n* Allergies to components\u002Fcompounds used to formulate selenium or placebo supplements.\n* Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis (Clostridium difficile, cytomegalovirus (CMV), any other pathogenic illness felt by the investigator to be the source of colitis).\n* Concern for impending need for hospitalization or urgent colectomy as determined by the treating provider(s) and\u002For investigator performing screening\u002Fevaluation for enrollment.\n* Unwillingness or inability to be compliant with selenium supplementation, adjustments in diet if necessary, or complete study-related visits\u002Fbiospecimen collection.","85 Years",{"count":432,"type":21},180,[87],"Micronutrient deficiencies are common in ulcerative colitis (UC). Selenium deficiency is associated with worse disease outcomes including disease flares and need for surgery. Previous in vitro and in vivo studies demonstrated that selenium regulates colonic inflammation, and that selenium supplementation protects against DSS-induced colitis. In this proof-of-concept clinical trial, we aim to test the hypothesis that selenium supplementation in moderate to severely active UC patients will improve responsiveness to advanced therapy such as biologics and small molecules.",[26],[437,438,439,281],"selenium supplementation","ulcerative colitis","selenomethionine","2026-05-20",{"date":412,"type":36},{"date":443,"type":36},"2026-04-29",{"date":184,"type":21},{"name":446,"class":43},"Northwestern University",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":456,"conditions":457,"keywords":458,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":467},"100613782","effectiveness-of-ozanimod-in-patients-with-steroid-dependent-ulcerative-colitis-100613782","NCT07271069","Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis","Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study","Inclusion Criteria:\n\n* Participants with Ulcerative Colitis (UC) provided written consent to participate in the study\n* Participants who are aged ≥ 18 years at the earlier date of either initiation of treatment with ozanimod or azathioprine or obtaining consent\n* Starting dose of oral steroid ≥ 30 mg\u002Fday (prednisolone equivalent)\n* Administration of ozanimod or azathioprine started after oral steroid administration, and ozanimod or azathioprine administered concomitantly with steroids (excluding patients who started oral steroids and ozanimod or azathioprine on the same day)\n* In the ozanimod group, patients with notable clinical symptoms due to the primary disease (rectal bleeding subscore ≥ 1 point or total PRO2 score ≥ 2 points) remained at the start of ozanimod administration\n* In the azathioprine group, patients who started azathioprine treatment after February 2019\n\nExclusion Criteria:\n\n* Participants with symptoms of UC with no change or increase in Patient-Reported Outcome 2 (PRO2) from the time of initiating oral steroid administration after 2 weeks of administration of ≥ 30 mg\u002Fday (prednisolone equivalent) of oral steroids\n* Participants with complications requiring continued steroid use (excluding topically acting steroids for inhalation or topical application)\n* Participants who participated in other clinical studies involving interventions during the observation period\n* Participants judged to be inappropriate for enrollment in this study by the investigator at each participating study site",{"count":455,"type":21},150,"The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan",[26],[26],"2026-05-15",{"date":368,"type":36},{"date":462,"type":36},"2026-01-29",{"date":464,"type":21},"2027-12-31",{"name":466,"class":102},"Bristol-Myers Squibb",18,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":475,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":478,"conditions":479,"keywords":480,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":74},"100628288","an-observational-study-to-learn-about-velsipity-after-long-term-use-in-patients-with-ulcerative-colitis-100628288","NCT07459686","An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis","Velsipity® Tablets 2 mg Special Investigation (Investigation on Long-Term Use in Patients With Ulcerative Colitis)","Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Patients with moderate to severe ulcerative colitis for whom treatment with this drug was started for the first time after the contract date for this study. Patients who have participated in a clinical study of this drug in the past or patients who have participated in this study are excluded.\n2. Patients who understand the contents of this study and give consent to provision of the information collected in this study to third parties and the use of it for other purposes.","0 Years",{"count":477,"type":21},553,"A study to assess the safety and effectiveness of Velsipity Tablets 2 mg during long-term treatment (up to a maximum of 52 weeks) in patients with ulcerative colitis under actual medical practice.",[26],[481],"Etrasimod, Velsipity, Ulcerative Colitis, UC","2026-05-14",{"date":368,"type":36},{"date":485,"type":36},"2026-04-27",{"date":487,"type":21},"2029-01-29",{"name":489,"class":102},"Pfizer",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":54,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":509,"leadSponsor":511,"locationsCount":210},"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":498,"type":21},76,[56],"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.",[25,26,27,502],"Anxiety",[504,505],"Virtual Reality","Cognitive Behavioral Therapy","2026-05-12",{"date":459,"type":36},{"date":205,"type":21},{"date":510,"type":21},"2027-07",{"name":512,"class":43},"Brennan Spiegel",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":520,"targetDuration":4,"studyType":54,"phases":522,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":530,"leadSponsor":532,"locationsCount":74},"100639162","phase-4-first-lines-of-biologics-in-patients-with-ulcerative-colitis-a-randomised-controlled-trial-100639162","NCT07576452","FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial","STARTER","Inclusion Criteria:\n\n* Male or female patients (using effective contraception and a negative pregnancy test for women of childbearing age) diagnosed with UC for at least 3 months\n* Age ≥ 18 years and ≤ 65 years\n* Moderate to severe UC according to modified Mayo score (from 5 to 9)\n* With endoscopic Mayo score ≥ 2\n* With an inadequate response, failure, loss of response, or intolerance to 5-ASA, steroids, or immunosuppressants.\n* Patient capable of giving consent\n* Patient covered by the French healthcare system\n* Women of childbearing age using active contraception (contraceptive implant, oral contraception, female condom or abstinence)) for at least the duration of the study\n\nExclusion Criteria:\n\n* Usual contra-indication to infliximab, filgotinib, vedolizumab or ustekinumab\n* Steroids \\> 20 mg\u002Fday within two weeks before inclusion\n* Low proctitis (disease limited to the rectum with an extent \\\u003C 5 cm)\n* Prior history of thromboembolism events\n* Prior history of major cardiovascular problems (such as heart attack or stroke)\n* Long-standing smokers (\\> 40 pack years)\n* Crohn's disease\n* Stoma or colectomy\n* Prior exposure to anti-TNF agents, anti-integrins, anti-interleukines 12 and 23 or JAK inhibitor\n* Prior exposure to other biologics or experimental drug\n* No health insurance\n* Pregnant or lactating women : a pregnancy test will be performed for women of childbearing age\n* Patients already included in biomedical research other than an observational study (e.g: registry, cohort)\n* Concomitant Clostridioides difficile infection\n* HIV infection\n* Patient who does not master the French language\n* Patient under guardianship, curatorship or safeguard of justice\n* Minors",{"count":521,"type":21},240,[523],"PHASE4","Ulcerative colitis (UC) is a chronic bowel disease. It causes inflammation of the rectum and sometimes the colon. This disease can also affect other parts of the body. It can be very difficult to live with on a daily basis. People with UC may experience frequent diarrhea, rectal bleeding, urgency to defecate, and even incontinence. All of this can significantly reduce their quality of life.\n\nThe goal of treatment is twofold:\n\n* To eliminate or reduce symptoms (this is clinical remission),\n* To allow the bowel to heal.\n\nWhen these two goals are achieved, the risk of relapse, hospitalization, surgery, or colorectal cancer decreases.\n\nTo monitor the progression of the disease, gastroenterologists use a test called fecal calprotectin: this is a protein measured in stool that helps detect intestinal inflammation.\n\nWhen conventional treatments like corticosteroids or immunosuppressants are ineffective or poorly tolerated, the investigators use more targeted therapies.\n\nFor a long time, doctors have used drugs called anti-TNFs. They block a protein responsible for inflammation (TNF-alpha). These treatments are often injected under the skin, which is generally well-tolerated by patients.\n\nA drug called infliximab, now available as a subcutaneous injection, could be used as a first-line treatment for ulcerative colitis because it appears to be more effective than other injectable anti-TNFs.\n\nAnother drug, vedolizumab, works differently from anti-TNFs and can also be used as a first-line treatment.\n\nMore recently, new classes of drugs have shown promise:\n\n* JAK inhibitors (such as filgotinib),\n* interleukin-12 and interleukin-23 inhibitors (such as ustekinumab).\n\nThese new treatments have advantages, such as the oral administration method for filgotinib and the fact that they can be used alone, without any other associated medication, which could simplify patients' lives and improve their quality of life.\n\nToday, there are increasingly more different treatments for ulcerative colitis, and the investigators still don't know clearly what the best strategy is:\n\nIs it better to start with one type of medication rather than another? Does the order in which the investigators try treatments lead to different results?\n\nThis is an important question for gastroenterologists, as their goal is to choose the most appropriate treatment for each patient from the outset.\n\nThe main objective of this research is to compare four strategies, corresponding to four treatment arms, starting with the use of infliximab, filgotinib, vedolizumab, or ustekinumab, to maintain remission in patients with ulcerative colitis.\n\nThe following four arms are therefore proposed:\n\n* Based on efficacy: infliximab - filgotinib - ustekinumab - vedolizumab\n* Based on safety: ustekinumab - vedolizumab - infliximab - filgotinib\n* Based on current practice: vedolizumab - infliximab - filgotinib - ustekinumab\n* Based on convenience and route of administration: filgotinib - ustekinumab - vedolizumab - infliximab\n\nThis study will also allow for a comparison of the efficacy, safety, participant acceptability, and quality of life of the four treatment regimens.\n\nThis study is intended for adult patients (aged 18 to 65), male or female, with moderate or severe ulcerative colitis (UC) for at least 3 months. Treatment for these patients must require biologic therapy, as determined by the investigator. Participants must be able to provide informed consent to participate in the research and must be covered by a national health insurance plan. Women of childbearing age must be using active contraception for at least the duration of the study (2 years).\n\nPatients will be followed for two years. They will be seen at the initial visit, then every two months during the first year, and then every three months during the second year. At each visit, they will be required to undergo blood and stool tests and complete a questionnaire. Endoscopies will be scheduled for weeks 16, 52, and 104. Patient treatments can be optimized once, and based on the endoscopic score, patients may change treatments according to a predefined sequence.",[26],"2026-05-11",{"date":528,"type":36},"2026-05-13",{"date":308,"type":21},{"date":531,"type":21},"2030-12-01",{"name":533,"class":43},"University Hospital, Clermont-Ferrand",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":549,"leadSponsor":550,"locationsCount":74},"100639884","research-on-the-whole-process-of-ai-intelligent-management-system-for-the-diagnosis-and-treatment-of-inflammatory-bowel-diseases-100639884","NCT07590271","Research on the Whole Process of AI Intelligent Management System for the Diagnosis and Treatment of Inflammatory Bowel Diseases","Inclusion Criteria:\n\nInclusion criteria for the IBD group:\n\nPatients diagnosed with IBD (K50.00 to K51.919) within the specified time interval.\n\nInclusion criteria for the non-IBD group:\n\nPatients never diagnosed with IBD (K50.00 to K51.919) within the specified time interval.\n\nExclusion Criteria:\n\nPatients not within the specified time interval Deceased patients\n\nExclusion criteria for the non-IBD group:\n\nPatients not within the specified time interval Deceased patients Patients with fewer than 5 hospital visits",{"count":541,"type":21},4500,"Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic immune-mediated disorder requiring long-term management. Clinically, IBD may involve recurrent intestinal inflammation, ulcer formation, and complications such as strictures and fistulas. The etiology of IBD is associated with immune dysregulation, gut microbiome imbalance, and genetic susceptibility. Its clinical manifestations are heterogeneous; early symptoms such as abdominal pain, diarrhea, weight loss, hematochezia, or anemia often resemble gastroenteritis, irritable bowel syndrome, or infectious enterocolitis, leading to misdiagnosis and delayed diagnosis. According to international studies, the interval between initial symptom onset and confirmed diagnosis can range from several months to years, during which untreated disease progression increases the risks of hospitalization, surgery, bowel strictures, and fistulizing complications, resulting in significant impacts on patient quality of life.\n\nThis study adopts a retrospective design, analyzing our hospital's electronic medical record data from 2023 to 2025.The objective is to evaluate the performance and feasibility of an artificial intelligence (AI) model-developed and incorporating natural language processing (NLP) and phenotypic recognition algorithms-in supporting early identification and diagnosis of IBD. The model has been validated in multiple European healthcare systems and is capable of recognizing high-risk phenotypic clusters from large-scale structured and unstructured medical data. This study represents the first application of this AI technology in the Taiwanese IBD population. All data processing will occur within a de-identified and secure computing environment to ensure data privacy and information security.\n\nThe study will compare AI-generated diagnostic suggestions derived from medical records with actual clinical diagnoses to assess consistency and accuracy. The model's performance across different clinical characteristics, disease severity levels, and stages of illness will also be examined. In addition, statistical metrics such as precision and recall will be used to generate PRC curves for determining the optimal diagnostic threshold. The outcomes of this study are expected to validate the potential of AI technology in facilitating early recognition, accelerating diagnosis, and supporting clinical decision-making for IBD. The findings will provide essential data for developing localized AI models for IBD, ultimately enhancing diagnostic efficiency, shortening the diagnostic timeline, and improving long-term patient outcomes and quality of life.\n\nObjective 1：To retrospectively analyze the clinical characteristics and diagnostic pathways of patients with IBD (CD\u002FUC).\n\nObjective 2：To evaluate the performance of the AI model in identifying and providing diagnostic suggestions for high-risk IBD cases.\n\nObjective 3：To compare the accuracy and consistency between AI-generated diagnostic suggestions and actual clinical diagnoses.",[544,408,26,545,546],"Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Artificial Intelligence (AI)","Natural Language Processing (NLP)",{"date":459,"type":36},{"date":308,"type":21},{"date":464,"type":21},{"name":551,"class":43},"Taichung Veterans General Hospital",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":210},"100626157","prospective-evaluation-of-the-carbon-footprint-and-clinical-utility-of-ibus-compared-to-colonoscopy-and-enterography-in-uc-and-cd-100626157","NCT07431983","Prospective Evaluation of the Carbon Footprint and Clinical Utility of IBUS Compared to Colonoscopy and Enterography in UC and CD","Prospective Evaluation of the Carbon Footprint and Clinical Utility of Intestinal Bowel Ultrasound Compared to Colonoscopy and Enterography in Ulcerative Colitis and Crohn's Disease","All consecutive patients undergoing endoscopy procedures with consent for procedures, during the study period will be included",{"count":404,"type":21},"Healthcare contributes approximately 4.4% of global GHG emissions, with diagnostic imaging and endoscopic services being substantial contributors. Colonoscopy and cross-sectional imaging modalities, though indispensable, are associated with high carbon emissions due to electricity use, waste, sterilisation, and transportation. IBUS, a non-invasive, real-time diagnostic modality, is increasingly validated for disease activity assessment in both UC and CD.",[26,562],"Crohns Disease",{"date":506,"type":36},{"date":565,"type":36},"2026-03-01",{"date":567,"type":21},"2026-12",{"name":569,"class":43},"Asian Institute of Gastroenterology, India",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":577,"enrollmentInfo":578,"targetDuration":4,"studyType":54,"phases":580,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":590,"locationsCount":74},"100622864","uneven-nutrition-and-life-style-as-ibd-triggers-in-adolescents-and-adults-100622864","NCT07389161","Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults","UNITA","Inclusion Criteria:\n\n* IBD, i.e., Mb Crohn or ulcerrative colitis\n* Moderatively active disease (calprotectin 200-600)\n\nExclusion Criteria:\n\n* Proctitis alone\n* Inactive disease\n* Severe flare up requiring in-patient care\n* Planned change of treatment\n* Antibiotic treatment during the last month\n* Pregnancy\n* Inability to understand Swedish\n* Multimorbidity","35 Years",{"count":579,"type":21},160,[56],"The aims of the study are 1. to determine the effect on dysbiosis, permeability and inflammatory activity after administration of a Mediterranean like diet (a Nordic equivalent, \"Nordiet\"), 2. to investigate life style related factors, such as exercise, psychosexual health and quality of life and their relation to the disease activity.",[583,26],"Mb Crohn",[585,122,583,120],"Diet","2026-04-28",{"date":443,"type":36},{"date":586,"type":36},{"date":310,"type":21},{"name":591,"class":43},"Region Skane",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":54,"phases":602,"briefSummary":603,"conditions":604,"keywords":607,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":614,"leadSponsor":616,"locationsCount":74},"100592363","multi-omics-dissection-of-gut-microbiome-engraftment-during-fmt-100592363","NCT06992453","Multi-omics Dissection of Gut Microbiome Engraftment During FMT","Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant","DissEcT","Inclusion Criteria:\n\nCoorte: Patients affected by Ulcerative Colitis\n\n* Age ≥18 years.\n* UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23)\n* UC during stable maintenance therapy (\\> 8 weeks with salicylates, immunosuppressants);\n* Ability to give informed consent.\n\nCoorte: Patients affected by metabolic syndrome\n\n* Age ≥18 years.\n* Patients with MetS (high glycaemia levels (\\> 100 mg\u002FdL), hypertension (\\> 130\u002F85 mmHg), raised triglyceride levels (\\> 150 mg\u002FdL), low high-density lipoprotein cholesterol levels (\\\u003C 40 mg\u002FdL in men; \\\u003C50 mg\u002FdL in women), and abdominal obesity (waist circumference of \\> 102 cm in men; \\>88 cm in women)\n* Stable treatment (\\> 8 weeks) of one of these disorders, included in MetS definition.\n* Ability to give informed consent\n\nCoorte: Patients affected by rCDI\n\n* Age ≥18 years\n* Mild recurrent Clostridioides difficile infection (26)\n* Ability to give informed consent.\n\nExclusion criteria\n\n* Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women).\n* Known active gastrointestinal disorders (e.g. infectious gastroenteritis except CDI, coeliac disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) apart from UC, with clinical characteristics reports in inclusion criteria.\n* Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI)\n* Previous colorectal surgery or cutaneous stoma\n* Critical and severe comorbidities\n* Inability to give informed consent.",{"count":601,"type":21},90,[56],"The gut microbiota plays a key role in immunity and metabolism and contributes to diseases such as recurrent C. difficile infection (rCDI), ulcerative colitis (UC), and metabolic syndrome (MetS). Microbiota therapeutics, particularly fecal microbiota transplantation (FMT), show promise-achieving \\~90% cure rates in rCDI-but demonstrate variable efficacy in chronic conditions. Microbiome engraftment appears critical for FMT success, yet consistent predictors remain lacking. A meta-analysis of 20 FMT studies by our group and the Segata Lab linked engraftment to clinical response across diseases, with taxon-specific patterns and ML-based predictability. While viral, fungal, host immune, genetic, and metabolic factors may affect engraftment, their roles are not well-defined. Key unresolved questions include the interplay among host factors, microbial strains, and metabolites, their influence on engraftment, and impact on clinical outcomes. This study aims to unravel microbiome engraftment dynamics and link them to therapeutic response.",[605,26,606],"Recurrent C. Difficile (rCDI)","Metabolic Syndrome (MetS)",[608,609,610],"Microbiome engraftment","Gut ecosystem","Fecal microbiota transplantation","2026-04-23",{"date":586,"type":36},{"date":611,"type":21},{"date":615,"type":21},"2029-02-19",{"name":617,"class":43},"Catholic University of the Sacred Heart",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":54,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":74},"100523431","efficacy-and-safety-of-vedolizumab-combined-with-upadacitinib-in-patients-with-ulcerative-colitis-100523431","NCT06095596","Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis","Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis\n* Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2\n* Indications for VDZ or UPA application\n\nExclusion Criteria:\n\n* Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy\n* Evidence of toxic megacolon was found during screening\n* Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC\n* Subjects who require surgery due to UC or plan to undergo elective surgery during the study period\n* There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases\n* Evidence of active hepatitis B or C infection during screening",{"count":626,"type":21},334,[56],"It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.",[26],"2026-04-22",{"date":586,"type":36},{"date":633,"type":36},"2023-11-01",{"date":635,"type":21},"2026-10-31",{"name":637,"class":43},"Sixth Affiliated Hospital, Sun Yat-sen University"]