Multi-omics Dissection of Gut Microbiome Engraftment During FMT (NCT06992453) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Italy90 participantsStarted 2026-04-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Longitudinal Analysis of Host-Microbiome Interactions Driving Microbial Engraftment