Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal i… (NCT07711509) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
China35 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal