Autologous Fecal Microbiota Transplantation: Autologous fecal microbiota transplantation will be prepared from the participant's own fecal material collected from the ileostomy output. Approximately 50 g of fecal material will be mixed with 100 mL sterile normal saline, homogenized, filtered through sterile sieves, and administered slowly into the distal bowel via transanal catheter/enema. The procedure will be performed once weekly at postoperative weeks 8, 9, 10, and 11, for a total of four administrations. Participants will be observed after the procedure according to the study protocol.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18 to 75 years.
2. Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge.
3. Undergoing radical rectal cancer surgery with protective loop ileostomy.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Able to understand the study procedures and willing to provide written informed consent.
Exclusion Criteria:
1. History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease.
2. Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions.
3. Pregnant or lactating women.
4. Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator.
5. Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy.
6. Poor compliance, inability to tolerate the intervention, or judged by the investigator to be unsuitable for participation in this clinical study.
7. Severe postoperative complications such as anastomotic leakage.
Primary outcome measure(s)
Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal — 3 months after ileostomy reversal Low Anterior Resection Syndrome (LARS) score will be assessed using the LARS questionnaire at 3 months after ileostomy reversal. The total score ranges from 0 to 42 points, with higher scores indicating more severe bowel dysfunction. Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS.
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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