[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629677":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal microbiota","EXPERIMENTAL","FMT with stools from healthy donors 3 sessions of FMT in addition to standard UDCA therapy. First session of FMT: during a colonoscopy. Second and third session of FMT: 20 FMT capsules at week 12 and 24",[13],"Drug: Fecal microbiota transplantation (FMT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham transplantation","SHAM_COMPARATOR","3 sessions of sham transplantation in addition to standard UDCA therapy. First session of sham transplantation: during a colonoscopy Second and third session of sham transplantation: 20 placebo capsules at week 12 and 24.",[19],"Drug: Sham-transplantation (placebo)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fecal microbiota transplantation (FMT)","One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy.\n\nThe patient will then receive either FMT (suspension of 50g of stools in 300ml of cryopreservative solution) in the terminal ileum or the caecum.\n\nAt W12 and W24 after first colonoscopy , the patient will receive orally 20 FMT (capsules swallowed in front of a physician or a nurse in hospital)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham-transplantation (placebo)","One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy.\n\nThe patient will then receive sham transplantation (FMT vehicle, i.e. 300ml of cryopreservative solution) in the terminal ileum or the caecum.\n\nAt W12 and W24 after first colonoscopy , the patient will receive orally 20 sham capsules (capsules swallowed in front of a physician or a nurse in hospital)",[15],[32],{"name":33,"affiliation":34,"role":35},"Sara LEMOINNE, MD, PhD, PU-PH","APHP","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+33 1 49 28 28 36","+33","sara.lemoinne@aphp.fr",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hepatology Department, Saint Antoine Hospital","Paris","75012","France","FR",{"type":50,"coordinates":51},"Point",[52,53],2.3488,48.85341,{"lat":53,"lon":52},[56],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100629677","phase-2-fecal-microbiota-transplantation-for-primary-sclerosing-cholangitis---randomized-study-versus-sham-transplantation-100629677",false,"NCT07477782","Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation","FMT-SCLER","Inclusion Criteria:\n\n* Males or females\n* Age ≥18 and ≤75 years\n* Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and \u002For extrahepatic biliary duct changes consistent with PSC\n* IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs)\n* IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment)\n* ALP ≥ 1.3 ULN (at least 2 times within a 3 months pre-inclusion period) or elevated total bilirubin ≤50 umol\u002Fl (with concomitant elevated direct bilirubin).\n* Treatment with UDCA (13-23 mg\u002Fkg\u002Fd) for at least 6 months and at the same dosage for at least 3 months\n* Using contraceptive in women of childbearing potential and agrees to pursue it from inclusion until week 48. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly.\n* Written informed consent signed\n* Subject affiliated to the French\n* Social Security System\n\nExclusion Criteria:\n\n* Small duct PSC\n* Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT \\> 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG \\> 1.5 ULN\n* Secondary sclerosing cholangitis (notably IgG4-associated cholangitis)\n* Cirrhosis defined by Liver elastometry \\>14.4 kPa or by current or past decompensation of cirrhosis\n* AST or ALT \\> 7 ULN in the last 3 months\n* Platelets count in the last 3 months \\\u003C 100 000\u002Fmm3\n* Albumin in the last 3 months \\\u003C35g\u002FL\n* Prothrombin index in the last 3 months \\\u003C 70%\n* Hepatic comorbidity: HBV infection (defined by positive Ag HBS), HCV infection (defined by positive HCV RNA), alcohol abuse (defined by alcohol intake \\> 30g\u002Fday), metabolic dysfunction associated steatohepatitis, primary biliary cholangitis, Hemochromatosis, Wilson disease, α1-antitrypsin deficiency, celiac disease\n* History of acute cholangitis in the last 3 months prior to inclusion or current acute cholangitis\n* HIV infection\n* Prior liver transplantation\n* Endoscopic treatment for bile duct stenosis ≤ 3 months prior to inclusion or planned within 3 months post randomization date\n* History of or established or suspected hepatobiliary carcinoma.\n* Any severe comorbidity that may reduce life expectancy\n* History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to inclusion)\n* Dosage changes of treatment for liver disease in the last 3 months or new treatment for liver disease started in the last 3 months\n* History of colorectal carcinoma or high-grade dypsplasia in previous screening colonoscopy\n* History of total colectomy\n* Current active IBD defined by a partial Mayo score \\> 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn's Disease Activity Index (CDAI) \\> 150 in patients with Crohn's disease\n* Changes in IBD treatment or initiation of a new treatment for IBD in the last 3 months\n* Current treatment with biologics (anti-TNF agent, vedolizumab, ustekinumab) or JAK inhibitors (tofacitinnib) or prednisone \\> 10 mg\u002Fday or budesonide \\> 3 mg \u002Fday) (or treatment initiated less than one month)\n* Any contra-indication to swallow capsules\n* Renal insufficiency (clearance\\\u003C60 ml\u002Fmin)\n* Unable to consent, subject to legal or administrative decision (protection measure or deprivation of liberty) or involuntary psychiatric care.\n* Participation in another interventional research without prior consultation with the investigator responsible for the patient's monitoring in the present study (participation in other non-interventional studies is permitted)\n* Pregnancy or desire for pregnancy or breastfeeding\n\nRandomization criteria\n\n* No pregnancy (or desire for in the next year)\n* No other hepatic pathology: HBV (positive HBs Ag), HCV (positive HCV antibody and positive PCR), autoimmune hepatitis\n* No HIV infection (positive serology HIV1+2 antibodies)\n* No documented Clostridium difficile infection at inclusion or \\\u003C 10 days preceding randomization (in case of infection discovered at inclusion)\n* No treatment with antibiotics, antifungics or probiotics \\\u003C 4 weeks.\n* Available FMT with EBV and CMV compatibility","ALL","18 Years","75 Years",{"count":70,"type":71},72,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.",[77,78],"Primary Sclerosing Cholangitis (PSC)","Inflammatory Bowel Disease (IBD)",[80,81,82,83,84,85],"Primary Sclerosing Cholangitis","inflammatory bowel disease","fecal microbiota transplantation","ursodeoxycholic acid","alkaline phosphatase","bilirubin","NOT_YET_RECRUITING","2026-03-12",{"date":89,"type":90},"2026-03-17","ACTUAL",{"date":92,"type":71},"2026-05",{"date":94,"type":71},"2030-05",{"name":5,"class":6},1]