NCT03516461

Fecal Microbiota Transplantation for Radiation Enteritis

Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Enteritis

Interventions

Type	Name	Description
PROCEDURE	Fecal Microbiota Transplantation (FMT)	Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy or colonic TET tube

Timeline

• Start date: 2018-01-07
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2018-05-04
• Last updated: 2025-03-30

Locations

1 site across 1 country: China