Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

Recruiting now · Phase 2

Conditions studied: Radiation Induced Proctitis

In brief

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.

Key facts

Study ID

NCT06776029

Run by

Sixth Affiliated Hospital, Sun Yat-sen University

People needed

20

Starts

2025-02-01

Expected to finish

2026-06-30

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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