Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

Phase 2

Recruiting

• Conditions: Radiation Induced Proctitis
• Interventions: Biological: Fecal Microbiota Transplantation Capsule

• Registration Number: NCT06776029
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-15
• Study Start: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation	Fecal Microbiota Transplantation Capsule	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with mild rectal bleeding (grade 0-1)	At the time of 12 weeks since the start of treatment	The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Secondary Outcome Measures

Name	Time	Method
Number of participants with mild rectal bleeding (grade 0-1)	At the time of 24 weeks since the start of treatment	The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Number of participants with improved colonoscopic findings	At the time of 12 and 24 weeks since the start of treatment	The colonoscopic findings will be assessed by the Vienna Rectoscopy Score.

Trial Locations

Locations (1)

The Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China