Cure8 trial brief
If donor ethnicity or specific microbial/metabolite signatures influence FMT success, results could help identify optimal donors or develop targeted microbiota-based treatments for ulcerative colitis.
Adults with ulcerative colitis, clinicians offering or considering FMT, researchers studying the microbiome and translational microbiota therapies, and people interested in personalized microbiome interventions.
This is a recruiting, randomized, parallel-group Phase 2 study enrolling 200 adults with left-sided UC. Participants receive three FMT infusions via transendoscopic enteral tubing (TET) and are evaluated at 12 weeks for clinical and endoscopic remission using Mayo scores and laboratory markers (fecal calprotectin, CRP, ESR).
The protocol includes metagenomic and metabolomic analysis of stool and follow-up lab/experimental work to identify microbes or metabolites that may explain any differences between donor groups. The trial uses screened healthy donors from two Yunnan ethnic groups (Dai vs Han) and limits other therapies to mesalazine to reduce confounding.
The study aims both to confirm prior signals that Dai donors may be more effective and to discover transferable microbial signatures that could guide personalized microbiota therapies.
This is a Phase 2 randomized trial protocol registered on ClinicalTrials.gov and currently recruiting. Outcomes will measure remission at 12 weeks; mechanistic findings will come from sequencing/metabolomics and lab validation. As a trial record, it describes planned methods rather than completed results.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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