Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Induced Proctitis
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation Capsule

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiyuan Qin, M.D.; Phone Number: 86-20-38254052; Email: qinqy3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The sixth affiliated hospital of Sun Yat-Sen University
      • Contact: Qiyuan Qin, M.D., Ph.D.; Phone Number: 86-20-38254052; Email: qinqy3@mail.sysu.edu.cn
      • Principal Investigator: Qiyuan Qin, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fecal Microbiota Transplantation; 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.

Biological: Fecal Microbiota Transplantation Capsule; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: fecal microbiota transplantation; rectal bleeding; radiation proctitis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Gastroenteritis; Proctitis
• Other Study ID Numbers: CRP202401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No