About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fecal microbiota transplantation (FMT)

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

1
Catholic University of the Sacred Heart00168, RomeRM, Italy

Sponsors and collaborators

Catholic University of the Sacred Heart

Lead sponsor