Clinical trial NCT03516461: Fecal Microbiota Transplantation for Radiation Enteritis
Official title: Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Enteritis
Keywords: Gut Microbiota
Radiation Enteritis
Fecal Microbiota Transplantation
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangxi Provincial Cancer Hospital
First posted: 2018-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 fecal microbiota transplantation (FMT) for radiation enteritis.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. age ≥18 years old;
2. Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

Exclusion Criteria:

1. Patients who were pregnant or nursing;
2. Patients who were unable or unwilling to undergo a gastroscopy;
3. Patients who had gastrointestinal infection;
4. Patients with cardiopulmonary failure.

Primary outcomes:
measure: Clinical response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Scores of gastrointestinal symptoms
timeFrame: 4, 8, 12 weeks
measure: Change of toxicity grade
timeFrame: 4, 8, 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, MD; PHD
role: PRINCIPAL_INVESTIGATOR
References:
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