Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.

NCT Number	NCT07149441
Lead Sponsor	Shanghai 10th People's Hospital
Conditions	Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Fecal Microbiota Transplantation
Enrollment	94 participants
Start Date	2025-08-01
Primary Completion	2028-09-01 (estimated)
Study Completion	2028-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-02