How donor gut bacteria take hold after a fecal transplant
Studies fecal transplant in recurrent CDI, ulcerative colitis and metabolic syndrome.
Plain-language title generated from the registry record
Registry title: Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Key facts
- Where
- Rome, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ulcerative colitis, metabolic syndrome, or a mild repeat Clostridioides difficile infection. It studies how fecal transplant changes the gut microbiome.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Ulcerative colitis: mild-to-moderate activity (total Mayo score 3-10 and endoscopic subscore of at least 1). Metabolic syndrome: high blood sugar, high blood pressure, high triglycerides, low HDL cholesterol and abdominal obesity, as defined in the record. C. difficile: mild recurrent infection.
- Earlier treatment
- Ulcerative colitis: stable maintenance treatment for more than 8 weeks (salicylates, immunosuppressants). Metabolic syndrome: stable treatment for more than 8 weeks. Antibiotics or other antimicrobials in the 4 weeks before screening are not allowed, except for people with recurrent C. difficile.
Main reasons for not taking part
- Pregnancy or breastfeeding, or refusing effective contraception during the study
- Other active gut diseases, such as infectious gastroenteritis (other than C. difficile), coeliac disease or irritable bowel syndrome
- Antimicrobial treatment in the 4 weeks before screening (except in recurrent C. difficile)
- Previous colorectal surgery or a skin stoma
- Critical and severe other illnesses
Read by machine on 12 November 2026.
Where in Italy
- Catholic University of the Sacred HeartRome, ItalyContact: Gianluca Ianiro, MD,PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Catholic University of the Sacred Heart
- Trial code
- NCT06992453
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant
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.
Inclusion: 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: Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI); Previous colorectal surgery or cutaneous stoma; 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; Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women); Critical and severe comorbidities; Inability to give informed consent.