Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study

Area of Science:

• Gastroenterology
• Microbiology
• Immunology

Background:

• Gut microbiota dysbiosis is linked to inflammatory and immunological diseases like ulcerative colitis (UC).
• Fecal microbiota transplantation (FMT) is a potential therapy to restore gut microbial diversity and manage UC.
• Current research lacks consensus on optimal FMT dosage, administration route, and response duration for UC.

Purpose of the Study:

• To explore the feasibility of FMT in treatment-naïve patients with distal UC.
• To estimate the magnitude of treatment response to FMT under controlled conditions.
• To assess the clinical utility of metabolic phenotyping in predicting FMT response and to evaluate donor/patient recruitment rates for future studies.

Main Methods:

• A single-blinded randomized trial involving 30 patients with distal UC.
• Patients randomized to receive a single FMT dose, five daily FMT doses, or no FMT (control).
• FMT administered via rectal retention enema after antibiotic gut decontamination and bowel preparation; 12-week follow-up.

Main Results:

• Feasibility of conducting FMT trials in distal UC patients was assessed.
• The study provided estimates for sample size and optimal conditions for a definitive Phase III trial.
• Data on treatment response and the role of metabolic phenotyping were collected.

Conclusions:

• This feasibility trial provides crucial data for designing a definitive Phase III study on FMT for ulcerative colitis.
• Findings will inform optimal study parameters, including endpoints and patient selection.
• FMT shows promise as a therapeutic option for UC, warranting further investigation.