Clinical Trial

Autologous Fecal Microbiota Transplantation for Diversion Colitis

Completed
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Summary
Diversion colitis (DC) is a common inflammatory complication in patients with temporary ileostomy after rectal cancer surgery, and no standardized medical treatment exists. This prospective, assessor-blinded, parallel-group, randomized controlled trial evaluated whether autologous fecal microbiota transplantation (auto-FMT) delivered through the diverting stoma ameliorates DC and improves post-reversal outcomes. Sixty-six patients with endoscopically confirmed DC were randomized 1:1 to receive daily auto-FMT (n=33) or saline irrigation (n=33) for four weeks. The primary endpoints are changes from baseline to week 4 in endoscopic (modified Harig score, 0-12) and histopathological (0-9) scores. Secondary endpoints include Wexner incontinence score, quality of life (EORTC QLQ-C30/CR29), inflammatory biomarkers, and safety. The study is designed to test whether auto-FMT produces superior improvements in endoscopic and histopathological severity compared with saline control, and leads to better functional outcomes after stoma reversal.
Trial Details
NCT Number NCT07674186
Lead Sponsor Yongjian Liao
Conditions Diversion Colitis
Enrollment 66 participants
Start Date 2022-06-01
Primary Completion 2025-03-31 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-29