Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Not applicable · Testing Fecal microbiota transplantation (FMT) · 1 site · Catholic University of the Sacred Heart
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal microbiota transplantation (FMT). Condition(s) listed: Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC) and Metabolic Syndrome (MetS).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Coorte: Patients affected by Ulcerative Colitis
- Age ≥18 years.
- UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23)
Plus 11 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 90 participants are expected to take part.
- Start date: 2026-04-23 (planned).
- Main results expected around 2029-01-19 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- Longitudinal Analysis of Host-Microbiome Interactions Driving Microbial Engraftment (60 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Recurrent C. Difficile (rCDI); Ulcerative Colitis (UC); Metabolic Syndrome (MetS) |
| Lead sponsor | Catholic University of the Sacred Heart |
| Enrollment | 90 (estimated) |
| Start date | 2026-04-23 |
| Primary completion (est.) | 2029-01-19 |
| First posted | 2025-05-28 |
| Last updated | 2026-04-28 |
| Official title | Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant |
| ClinicalTrials.gov ID | NCT06992453 |
Interventions
- Fecal microbiota transplantation (FMT) (Other)
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 d…
Full eligibility criteria (from the record)
Inclusion Criteria: Coorte: Patients affected by Ulcerative Colitis * Age ≥18 years. * UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23) * UC during stable maintenance therapy (> 8 weeks with salicylates, immunosuppressants); * Ability to give informed consent. Coorte: Patients affected by metabolic syndrome * Age ≥18 years. * 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) * Stable treatment (> 8 weeks) of one of these disorders, included in MetS definition. * Ability to give informed consent Coorte: Patients affected by rCDI * Age ≥18 years * Mild recurrent Clostridioides difficile infection (26) * Ability to give informed consent. Exclusion criteria * Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women). * 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. * Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI) * Previous colorectal surgery or cutaneous stoma * Critical and severe comorbidities * Inability to give informed consent.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Catholic University of the Sacred Heart | Rome, RM | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.