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

NCT07711509 | Active Not Recruiting

• 1 other identifier: PKUPH-FMT-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Low Anterior Resection Syndrome; Fecal Incontinence; Diversion Colitis; Ileostomy; Gut Microbiota Dysbiosis

Keywords

autologous fecal microbiota transplantation; rectal cancer; ileostomy reversal; low anterior resection syndrome; LARS score; diversion colitis; gut microbiota; 16S rRNA sequencing; anal function; bowel function

Outcome Measures

Primary Outcomes (1)

• Low Anterior Resection Syndrome Score at 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.

  3 months after ileostomy reversal

Secondary Outcomes (1)

• Colonoscopic Mucosal Findings Before Ileostomy Reversal

  Approximately 12 weeks after initial surgery and before ileostomy reversal

Study Arms (1)

Autologous Fecal Microbiota Transplantation Group

EXPERIMENTAL

Participants with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy will receive autologous fecal microbiota transplantation before ileostomy reversal.

Biological: Autologous Fecal Microbiota Transplantation

Interventions

Autologous Fecal Microbiota Transplantation BIOLOGICAL

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.

Autologous Fecal Microbiota Transplantation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years.
• Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge.
• Undergoing radical rectal cancer surgery with protective loop ileostomy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Able to understand the study procedures and willing to provide written informed consent.

You may not qualify if:

• History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease.
• Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions.
• Pregnant or lactating women.
• Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator.
• Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy.
• Poor compliance, inability to tolerate the intervention, or judged by the investigator to be unsuitable for participation in this clinical study.
• Severe postoperative complications such as anastomotic leakage.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome; Fecal Incontinence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: March 25, 2025
• Primary Completion: May 20, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)