Overview
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 Criteria:
- 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 Criteria:
- 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
