[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496103":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Donor FMT (D-FMT)","EXPERIMENTAL","Patients enrolled in this arm will receive donor FMT",[13],"Biological: FMT",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo FMT (P - FMT)","PLACEBO_COMPARATOR","Patients enrolled in this arm will receive placebo FMT",[19],"Other: Placebo FMT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","FMT","This intervention is represented by the administration, in the recipients' gut, of super - donor microbiota through FMT",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo FMT","This intervention is represented by the administration, in the recipients' gut, of a placebo through FMT",[15],[32],{"name":33,"affiliation":5,"role":34},"Gianluca Ianiro","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Gianluca Ianiro, MD","CONTACT","+39 0630157338","gianluca.ianiro@unicatt.it",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Serena Porcari, MD","porcariserena89@gmail.com",[45],{"facility":33,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Rome","Lazio","00168","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],12.51133,41.89193,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":39,"phoneExt":26,"email":40},"Gianluca Ianiro, MD, Phd",{"type":34,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"IANIRO GIANLUCA","Dr.","100496103","phase-1-superdonor-fmt-in-patients-with-ulcerative-colitis-100496103",false,"NCT05739864","Superdonor FMT in Patients With Ulcerative Colitis","Evaluation of the Efficacy of Superdonor Fecal Microbiota Transplantation in Patients With Mild-to-moderate Ulcerative Colitis: a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 75 years old\n* Mild to Moderate Ulcerative Colitis (total Mayo score 3 -10 + endoscopic subscore ≥ 1) in stable maintenance therapies (\\> 4 weeks with Aminosalicylates, \\> 6 weeks with immunosuppressant or biologics agents);\n* Recent diagnosis (\\\u003C 12 months) of Ulcerative Colitis;\n* Ability to provide written informed consent\n* Ability to be compliant with the scheduled procedures\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, Crohn disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)\n* Previous colorectal surgery or cutaneous stoma\n* Current or recent (\\\u003C 2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors or metformin)\n* Decompensated heart failure or heart disease with ejection fraction lower than 30%\n* Severe respiratory insufficiency\n* Psychiatric disorders\n* Pregnancy or breastfeeding\n* Unable to give informed consent","ALL","18 Years","75 Years",{"count":75,"type":76},42,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","In the last decades fecal microbiota transplantation (FMT) has been established as a highly effective option in the treatment of recurrent Clostridioides difficile infection (rCDI), with a success rate of nearly 90%. For this reason, it is recommended by international guidelines as a treatment option for this indication in clinical practice.\n\nRecently, a considerable body of evidences, suggest FMT as an effective and safe treatment in patients affected by Ulcerative Colitis (UC). In a recent meta-analysis of 324 subjects with UC, 30.4% of patients achieved both clinical and endoscopic remission after FMT compared to placebo (9.8%, P\\\u003C0.00001). However, among the various published trials there is a fair variability in terms of methods and results, which are not comparable to those obtained in the rCDI.\n\nNowadays, one of the most critical factors involved in the effectiveness of FMT in UC patients, is the choice of the donor.\n\nIn addition, several studies have shown that some donors are associated with a higher clinical response rate than others. This hypothesis has been demonstrated in patients affected by irritable bowel syndrome, in which the use of a super-donor (a healthy person who has the predictive clinical and lifestyle characteristics of a healthy microbiota, and with a microbial profile associated with favorable clinical conditions) resulted in significantly higher clinical efficacy rates than placebo, similar to those obtained in rCDI (89%).\n\nCurrently, studies that explored the efficacy of the super-donor FMT in UC patients are not yet available. Aim of this study is to investigate the efficacy of super - donor FMT, compared with placebo FMT, in the treatment of UC. The investigators will randomize adult patients with a recent diagnosis of UC to FMT from super - donors or placebo, by colonoscopy (first infusion) and capsules administration. Then, patients will be followed up 2 months after FMT.",[83],"Active Ulcerative Colitis",[85,86,87],"Ulcerative Colitis","Fecal Microbiota Trasplantation","Super - donor","2026-03-17",{"date":90,"type":91},"2026-03-19","ACTUAL",{"date":93,"type":91},"2023-02-13",{"date":95,"type":76},"2027-02-14",{"name":5,"class":6},1]