Multi-omics Dissection of Gut Microbiome Engraftment During FMT

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.

NCT Number	NCT06992453
Lead Sponsor	Catholic University of the Sacred Heart
Conditions	Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC), Metabolic Syndrome (MetS)
Enrollment	90 participants
Start Date	2026-04-23
Primary Completion	2029-01-19 (estimated)
Study Completion	2029-02-19 (estimated)
Updated on ClinicalTrials.gov	2026-04-28