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Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Summary
The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy. The main questions it aims to answer are: * Dose FMT alleviate the symptom of severe rectal bleeding? * Dose FMT improve the endoscopic findings of proctopathy? Participants will: * Take fecal microbiota capsules by 8 sessions over a 12-week period. * Visit the clinic once every 4 weeks for checkups and tests. * Keep a diary of their symptoms and the number of times they use other supportive care.
Official title: A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-02-01
Completion Date
2026-06-30
Last Updated
2025-03-10
Healthy Volunteers
No
Conditions
Interventions
Fecal Microbiota Transplantation Capsule
FMT is delivered via oral capsules. Fecal microbiota capsules are given by 8 sessions over a 12-week period, with the initial 3 sessions every other day in the first week and the subsequent sessions every two weeks. The FMT regimen involves oral intake of 40 capsules per session. The best supportive care is performed when necessary, including oral medicine, enema, blood transfusion, and endoscopic procedures.
Locations (1)
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China