Fecal Microbiota Transplantation for Radiation Enteritis

Last updated: March 27, 2025
Sponsor: The Second Hospital of Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Infectious Colitis

Gastroenteritis

Treatment

Fecal Microbiota Transplantation (FMT)

Clinical Study ID

NCT03516461
FMT-RE-201702
  • Ages 18-85
  • All Genders

Study Summary

Radiation enteritis is one of the most feared complications after abdominal or pelvic radiation therapy.The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for radiation enteritis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age ≥18 years old;

  2. Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

Exclusion

Exclusion Criteria:

  1. Patients who were pregnant or nursing;

  2. Patients who were unable or unwilling to undergo a gastroscopy;

  3. Patients who had gastrointestinal infection;

  4. Patients with cardiopulmonary failure.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Fecal Microbiota Transplantation (FMT)
Phase:
Study Start date:
January 07, 2018
Estimated Completion Date:
July 01, 2025

Study Description

The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. At enrollment, "Shared Decision Making" intervention was applied to support patient involvement in making health decisions. Patients have opportunity to choose fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 12 weeks. Blood test, endoscopy and questionnaire will be used to access participants at study start and at study completion. Fecal microbiota compositions, blood and urinary metabolic profiles of patients will be analyzed to assess associated microbial changes.

Connect with a study center

  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

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