An interventional study of Fecal Microbiota Transplantation (FMT) in Radiation Enteritis, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
34 studies on the registry are indexed under Enteritis; 7 are open to participants now.
This study's planned enrollment of 70 is above the median of 53 across 26 interventional studies indexed under Enteritis.
Browse Enteritis studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Patients receive a course of FMT during hospitalization
Procedure: Fecal Microbiota Transplantation (FMT)
Patient receives basic therapy for RE during hospitalization
Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy or colonic TET tube
Also known as: FMT
Clinical response rate
The clinical response rate at 8 weeks after fmt treatment
Time frame: 12 weeks
Scores of gastrointestinal symptoms
Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0
Time frame: 4, 8, 12 weeks
Change of toxicity grade
The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4, 8, 12 weeks after FMT
Time frame: 4, 8, 12 weeks
Plan to share: Undecided
Started Jan 2018 (actual). Primary completion is estimated for Jul 2025, 89 months after the start.
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The Second Hospital of Nanjing Medical University