{ "data": { "asOf": "2026-10-30T22:25:17.657Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06992453", "title": "Multi-omics Dissection of Gut Microbiome Engraftment During FMT", "scientificTitle": "Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant", "status": "recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Recurrent C. Difficile (rCDI)", "Ulcerative Colitis (UC)", "Metabolic Syndrome (MetS)" ], "interventions": [ { "name": "Fecal microbiota transplantation (FMT)", "type": "OTHER", "description": "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." } ], "sponsor": { "name": "Catholic University of the Sacred Heart", "type": "OTHER" }, "locations": [ { "city": "Rome", "country": "Italy", "facility": "Catholic University of the Sacred Heart" } ], "outcomes": { "other": [], "primary": [ "Longitudinal Analysis of Host-Microbiome Interactions Driving Microbial Engraftment" ], "secondary": [ "Longitudinal Analysis of Host-Microbiome Interactions and Their Impact on Clinical Outcomes" ] }, "eligibility": { "sex": "ALL", "criteria": "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/dL), hypertension (\\> 130/85 mmHg), raised triglyceride levels (\\> 150 mg/dL), low high-density lipoprotein cholesterol levels (\\< 40 mg/dL in men; \\<50 mg/dL 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.", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 90 }, "startDate": "2026-04-23", "completionDate": "2029-02-19", "lastUpdated": "2026-10-26T00:00:00.000Z", "firstPosted": "2025-05-28T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT06992453" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT06992453", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06992453", "sourceUrl": "https://clinicaltrials.gov/study/NCT06992453", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:56.402Z", "payloadSha256": "aa07c776b62f7f3dab3defef235df31dee2f82988ee74deee2c984b910da6e96", "piiRedacted": true } ], "citation": { "canonicalId": "NCT06992453", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06992453", "verifyAt": "https://clinicaltrials.gov/study/NCT06992453", "retrievedAt": "2026-10-28T04:32:56.402Z", "payloadSha256": "aa07c776b62f7f3dab3defef235df31dee2f82988ee74deee2c984b910da6e96", "text": "ClinicalTrials.gov, record NCT06992453 (https://clinicaltrials.gov/study/NCT06992453), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT06992453, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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