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Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis
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.
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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Start Date
January 7, 2018
Primary Completion Date
July 1, 2025
Completion Date
July 1, 2025
Last Updated
March 30, 2025
70
ESTIMATED participants
Fecal Microbiota Transplantation (FMT)
PROCEDURE
Lead Sponsor
The Second Hospital of Nanjing Medical University
Collaborators
NCT06836960
NCT07331688
NCT05425901
Data Source & Attribution
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