Abstract

Background: Increasing evidence has indicated that gut microbiota is closely associated with radiationinduced bowel injury. We aimed to evaluate the safety and effificacy of fecal microbiota transplantation(FMT) in patients with chronic radiation enteritis (CRE).Methods: A pilot study of FMT for CRE was performed. The primary outcomes were safety and response toFMT which was defifined as a
1-grade reduction in Radiation Therapy Oncology Group (RTOG/EORTC)late toxicity grade from baseline, by 8 weeks post-FMT. The secondary outcomes included a decreasein the severity of four common symptoms (diarrhea, rectal hemorrhage, abdominal/rectal pain and fecalincontinence) in CRE and changes in Karnofsky Performance Status (KPS) score. Microbial analyses wereperformed by 16S rRNA sequencing.Results: Five female patients underwent FMT from January to November 2018 with a median age of 58(range 45–81) years. The median baseline RTOG/EORTC grade was 2 (range 2–4). Three patientsresponded to FMT and experienced improvement in diarrhea, rectal hemorrhage, abdominal/rectal painand fecal incontinence as well as a decrease in KPS score. No FMT-related death and infectious complications occurred. One mild FMT-related AE was observed during a follow-up ranged from 8 to 18 months.16S rRNA sequencing indicated that FMT altered the composition of gut microbiota of patients.Conclusion: The present case series fifirst demonstrated that FMT might be safe and effective to improveintestinal symptoms and mucosal injury in patients with CRE for a period of time.

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