Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

NCT06776029 | Recruiting Phase 2

• 1 other identifier: CRP202401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Induced Proctitis

Keywords

fecal microbiota transplantation; rectal bleeding; radiation proctitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of participants with mild rectal bleeding (grade 0-1)

  At the time of 24 weeks since the start of treatment

• Number of participants with improved colonoscopic findings

  At the time of 12 and 24 weeks since the start of treatment

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

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

Interventions

Fecal Microbiota Transplantation Capsule BIOLOGICAL

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.

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Qiyuan Qin, M.D.

CONTACT

86-20-38254052; qinqy3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: February 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)