Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

Last updated: March 5, 2025
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Hemorrhoids

Ulcerative Colitis (Pediatric)

Rectal Disorders

Treatment

Fecal Microbiota Transplantation Capsule

Clinical Study ID

NCT06776029
CRP202401
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/Lin the past 3 months

Exclusion

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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Fecal Microbiota Transplantation Capsule
Phase: 2
Study Start date:
February 01, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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