Microbiota Transplantation for Radiation Enteritis

Efficacy and Safety of Selective Microbiota Transplantation and 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 selective microbiota transplantation (SMT) and fecal microbiota transplantation (FMT) for radiation enteritis.

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through selective microbiota transplantation (SMT) or fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. SMT is the intermediate composition of bacteria between traditional probiotics and whole profile of microbiota; it aims to stimulate the efficiency 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 selective microbiota transplantation (SMT) or fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 4 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.

Gut Microbiota, Radiation Enteritis, Selective Microbiota Transplantation, Fecal Microbiota Transplantation

Patients undergo FMT on day 1. If they fail to benefit from single FMT, repeat FMTs (no more than 3 times) would be performed.

Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy (once per day and no more than 3 times)

Changes in functional status of patients will be assessed according to the Karnofsky Performance Status (KPS) scale (ranging from 0 [dead] to 100 [normal activity, no evidence of disease])

Inclusion Criteria: age ≥18 years old; Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy. Exclusion Criteria: Patients who were pregnant or nursing; Patients who were unable or unwilling to undergo a gastroscopy; Patients who had gastrointestinal infection; Patients with cardiopulmonary failure.

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