[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592363":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":47,"collaborators":27,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":27,"enrollmentInfo":61,"targetDuration":27,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":76,"whyStopped":27,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Catholic University of the Sacred Heart","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Recurrent C. difficile infection (rCDI) Cohort","EXPERIMENTAL","Patients with recurrent C. difficile infection (rCDI) will be recruited among those referred to the Digestive Disease Centre (CEMAD) of the Fondazione Policlinico Universitario A. Gemelli IRCCS. Patients with all inclusion criteria and none of the exclusion criteria will be considered for this study.",[13],"Other: Fecal microbiota transplantation (FMT)",{"label":15,"type":10,"description":16,"interventionNames":17},"Ulcerative Colitis (UC) Cohort","Patients with Ulcerative Colitis (UC) will be recruited among those referred to the Digestive Disease Centre (CEMAD) of the Fondazione Policlinico Universitario A. Gemelli IRCCS. Patients with all inclusion criteria and none of the exclusion criteria will be considered for this study.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Metabolic syndrome (MetS) Cohort","Patients with metabolic syndrome (MetS), will be recruited among those referred to the Digestive Disease Centre (CEMAD) and to the Endocrine and Metabolic Diseases Unit of the Fondazione Policlinico Universitario A. Gemelli IRCCS.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Fecal microbiota transplantation (FMT)","Patients will receive a first donor FMT by colonoscopy, after a pre-conditioning with vancomycin and neomycin + bacitracin for 3 days, because data from our group show that pre-FMT antibiotics are associated with higher rates of microbial engraftment. Then they will receive two cycles, respectively after 3 and 7 days after colonoscopy - FMT, of frozen donor FMT capsules (15 capsules b.i.d. per 3 days). Patients will always receive feces from the same donor.",[19,9,15],null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Gianluca Ianiro, MD, PhD","CONTACT","0630159539","gianluca.ianiro@unicatt.it",[35],{"facility":5,"status":27,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":27},"Rome","RM","00168","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],12.51133,41.89193,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Gianluca Ianiro","Principal Investigator, MD, PhD","100592363","multi-omics-dissection-of-gut-microbiome-engraftment-during-fmt-100592363",false,"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.","ALL","18 Years",{"count":62,"type":63},90,"ESTIMATED","INTERVENTIONAL",[66],"NA","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.",[69,70,71],"Recurrent C. Difficile (rCDI)","Ulcerative Colitis (UC)","Metabolic Syndrome (MetS)",[73,74,75],"Microbiome engraftment","Gut ecosystem","Fecal microbiota transplantation","NOT_YET_RECRUITING","2026-04-23",{"date":79,"type":80},"2026-04-28","ACTUAL",{"date":77,"type":63},{"date":83,"type":63},"2029-02-19",{"name":5,"class":6},1]