Fecal Microbiota Transplantation for Radiation Enteritis

Not Applicable

Recruiting

• Conditions: Radiation Enteritis
• Interventions: Procedure: Fecal Microbiota Transplantation (FMT); Procedure: Selective Microbiota Transplantation (SMT)

• Registration Number: NCT03516461
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-07
• Study First Submitted: 2018-01-07
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-04
• Status Verified: 2024-09
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. age ≥18 years old;
2. Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation (FMT)	Fecal Microbiota Transplantation (FMT)	Patients undergo FMT on day 1. If they fail to benefit from single FMT, repeat FMTs (no more than 3 times) would be performed.
Selective Microbiota Transplant (SMT)	Selective Microbiota Transplantation (SMT)	Patients undergo once SMT a day for three consecutive days.

Primary Outcome Measures

Name	Time	Method
Clinical response rate	12 weeks	The clinical response rate at 8 weeks after fmt treatment
Clinical response rate	8 weeks	The clinical response rate at 8 weeks after fmt treatment

Secondary Outcome Measures

Name	Time	Method
Scores of gastrointestinal symptoms	4, 8, 12 weeks	Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0
Change of toxicity grade	4, 8, 12 weeks	The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4, 8, 12 weeks after FMT

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China