[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microscopic-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microscopic-colitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100604950","phase-2-a-study-to-investigate-the-efficacy-and-safety-of-sar444336-in-adults-with-microscopic-colitis-in-clinical-remission-100604950",false,"NCT07156175","A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission","A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of SAR444336 in Participants With Microscopic Colitis in Clinical Remission With Budesonide","Inclusion Criteria:\n\n* Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types).\n* Receiving budesonide therapy.\n* Documented clinical remission from 2 weeks before screening.\n* At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide.\n* Body mass index within the range 18 to 35 kg\u002Fm2 (inclusive) at screening visit.\n* All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception.\n\nExclusion Criteria:\n\n* Significant neutrophilic\u002Feosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis.\n* Evidence of infectious diarrhea in the 3 months prior to randomization.\n* Other active diarrheal conditions or suspicion of drug--induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome.\n* Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization.\n* Previous bowel surgeries.\n* Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed.\n* Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment.\n* Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months.\n* History or presence of alcohol or illicit drug abuse within the past 2 years.\n* Excessive consumption of beverages containing xanthine bases.\n* History of solid organ transplant.\n* Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 2 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.\n* Have experienced any of the following within 12 months before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III or IV heart failure.\n* Participants with a history or presence of another significant illness such as renal, neurological, ophthalmological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic.\n* Live attenuated vaccines within 6 weeks of randomization and during the study.\n* Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents.\n* At screening, have abnormal laboratory values or ECG abnormalities.\n* Participants with recent tuberculosis (TB) vaccination or positive TB test results.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis. Participants are required to have a histologically confirmed diagnosis of microscopic colitis, be in clinical remission and be receiving budesonide therapy. The overall study duration is approximately 32 weeks.",[26],"Microscopic Colitis","RECRUITING","2026-09-18",{"date":30,"type":31},"2026-09-23","ACTUAL",{"date":33,"type":31},"2025-10-14",{"date":35,"type":20},"2027-05-06",{"name":37,"class":38},"Sanofi","INDUSTRY",24,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100509567","phase-2-efficacy-and-safety-of-budesonide-mmx-vs-budesonide-cr-for-induction-of-remission-in-microscopic-colitis-100509567","NCT05915104","Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis","Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis: A Prospective, Randomized, Active Comparator Pilot Study","Inclusion Criteria:\n\n* Male or non-pregnant, non-lactating females, 18-80 years old years of age\n* Females of childbearing potential must be taking adequate contraceptive precautions (i.e., implants, injectables, hormonal intrauterine devices, combined hormonal contraceptives, having a vasectomized partner or total abstinence from heterosexual relations with no plans of becoming pregnant through insemination or in vitro fertilization) and have a negative urine pregnancy test prior to randomization.\n* Active symptoms of MC defined by non-bloody, watery diarrhea or loose bowel movements for at least 12 weeks (for patients with newly diagnosed MC) or a history of clinical relapse for at least one week before randomization in patients with previously established MC, and with \\>=28 stools within 7 days preceding randomization, of which \\>=20 were watery\u002Fsoft stools\n* Colonoscopy or flexible sigmoidoscopy with histologically confirmed MC, defined by signs of inflammation of the lamina propria and either:\n* lymphocytic colitis: ≥20 IELs\u002F100 surface epithelial cells\n* collagenous colitis: subepithelial collagen band \\>10 micrometers in diameter\n* Ability of subject to participate fully in all aspects of this clinical trial\n* Written informed consent must be obtained and documented\n\nExclusion Criteria:\n\n* Evidence of infectious diarrhea (proved by stool culture or colonic biopsy), diarrhea due to other organic diseases of the gastrointestinal tract including Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease (ruled out by either duodenal biopsy or serum antibodies), radiation colitis, or polyps \\>2cm, suspicion of drug-induced MC\n* History of partial or total colonic resection\n* Previous exposure to \\>7 days of any budesonide formulation for treatment of MC\n* Unwillingness to withhold protocol-proscribed medications during the trial\n* Received any of: aminosalicylates, corticosteroids (other than budesonide), immunosuppressants (including thiopurines and methotrexate), bismuth subsalicylate, cholestyramine, biological treatments, or antibiotics (except for up to a 7-day course for conditions unrelated to microscopic colitis) within 8 weeks of randomization\n* Use of loperamide or diphenoxylate\u002Fatropine as an anti-diarrheal agent is not permitted during the screening period\n* Serious underlying disease other than MC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study, including a history of:\n* Severe anaemia (haemoglobin \\\u003C 90 g\u002FL) or leukopenia (white blood cell count \\\u003C 2.5 x 109 cells\u002FL)\n* Known infection with hepatitis B, hepatitis C, or human immunodeficiency virus not on effective anti-viral therapy\n* Active malignancy\n* Cirrhosis or significant hepatic or renal insufficiency\n* Poorly controlled type 1 or type 2 diabetes\n* Glaucoma\n* History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.\n* Pregnant or lactating women\n* Hypersensitivity to the active ingredient of budesonide MMX® or budesonide CR and excipients","80 Years",{"count":49,"type":20},80,[23],"The purpose of this research study is to compare how well two formulations of budesonide (budesonide MMX \\[Cortiment\\] and budesonide CR \\[Entocort\\]) work for treating patients with microscopic colitis.",[26],"NOT_YET_RECRUITING","2023-12-01",{"date":56,"type":31},"2023-12-04",{"date":58,"type":20},"2024-01-01",{"date":60,"type":20},"2026-12-31",{"name":62,"class":63},"University of Calgary","OTHER",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100365871","phase-2-efficacy-and-safety-of-oral-rifaximin-in-patients-with-active-microscopic-colitis-100365871","NCT04043897","Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis","Inclusion Criteria:\n\n* Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsies reviewed by 2 separate pathologists\n* CC will be defined histologically to be the following: thickness of the collagenous subepithelial table \\>10 micrometer using an ocular micrometer, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, lack of crypt architectural distortion, and regenerative-appearing changes in the surface and\u002For crypt epithelium\n* LC will be defined histologically to be the following: intraepithelial lymphocytes \\>20 per 100 epithelial cells in the subjective area of highest lymphocyte density, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, and regenerative-appearing changes in the surface and\u002For crypt epithelium\n* Subjects in active flare, defined as \\>3 watery\u002Floose stools per day on \\>4 \u002F 7 days over \\>4 weeks in the past 3 months.\n\nExclusion Criteria:\n\n\\-",{"count":71,"type":20},10,[23],"This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.",[26],[26],"2021-04-14",{"date":78,"type":31},"2021-04-15",{"date":80,"type":31},"2018-06-29",{"date":82,"type":20},"2021-12",{"name":84,"class":63},"Eugene F Yen, MD",1]