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Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

RecruitingPhase 2Ages 18 Years - 75 YearsAllSixth Affiliated Hospital, Sun Yat-sen University
NCT06776029 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Fecal Microbiota Transplantation Capsule
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Where

1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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