NCT07711509Active, not recruiting
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Patients With Rectal Cancer: A Prospective, Single-center, Single-arm, Open-label Clinical Study
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 14 Jul 2026
- Start date
- 25 Mar 2025
- Primary completion date
- 20 May 2026
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07711509
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 25 Mar 2025 to the primary completion date, 20 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy.
Other illness
- 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.
Other
- Pregnant or lactating women.
- Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.