Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
Sixth Affiliated Hospital, Sun Yat-sen University
20 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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
Exclusion Criteria10
- Acute or chronic infectious diseases
- Serious systemic diseases
- Known allergies to any components of the study medication
- Colonoscopy indicating rectal ulceration (>1cm2), fistula, stricture, or necrosis
- Late complications related to pelvic radiation injury
- Other hemorrhagic or coagulation disorders
- Previous rectal resection
- Bowel obstruction or perforation that require surgery
- Cognitive or psychological disorder
- Contraindications to FMT administration
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Interventions
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)
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NCT06776029