Microbiota Transplantation for Radiation Enteritis

Radiation Enteritis Clinical Trial

Official title: Efficacy and Safety of Selective Microbiota Transplantation and Fecal Microbiota Transplantation in Radiation Enteritis

Status Recruiting

Clinical Trial 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 selective microbiota transplantation (SMT) and fecal microbiota transplantation (FMT) for radiation enteritis.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Enteritis
• Radiation Enteritis

• NCT number: NCT03516461
• Study type: Interventional
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD; PHD
• Phone: 086-25-58509883
• Email: fzhang@njmu.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2018
• Completion date: December 2020