Clinical Trial

Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer

Active, Not Recruiting
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Summary
This prospective, single-center, single-arm, open-label clinical study aims to evaluate whether autologous fecal microbiota transplantation can improve bowel and anal function after ileostomy reversal in patients with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy. Eligible patients will receive autologous fecal microbiota transplantation before ileostomy reversal. The primary outcome is the Low Anterior Resection Syndrome score at 3 months after ileostomy reversal. Secondary outcomes include fecal incontinence score, colonoscopic findings before ileostomy reversal, gut microbiota profiles, inflammatory markers, anorectal manometry, pelvic floor electromyography, and safety outcomes.
Trial Details
NCT Number NCT07711509
Lead Sponsor Peking University People's Hospital
Conditions Rectal Cancer, Low Anterior Resection Syndrome, Fecal Incontinence, Diversion Colitis, Ileostomy, Gut Microbiota Dysbiosis
Enrollment 35 participants
Start Date 2025-03-25
Primary Completion 2026-05-20 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-17