A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age: 18-75 years old

• At least 3 months since the completion of pelvic radiotherapy

• No evidence of tumor recurrence or metastasis

• Rectal bleeding with grade 2-4 by LENT-SOMA scales

• Colonoscopy indicating rectal congested mucosa or telangiectasia

• Poor response to supportive care, or hemoglobin level less than or equal to 70 g/L in the past 3 months

Locations
Other Locations
China
The Sixth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Qiyuan Qin, M.D.
qinqy3@mail.sysu.edu.cn
86-20-38254052
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Experimental: Fecal Microbiota Transplantation
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.
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov