Radiation Enteritis
Conditions
Keywords
Gut Microbiota, Radiation Enteritis, Fecal Microbiota Transplantation
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.
Interventions
PROCEDUREFecal Microbiota Transplantation (FMT)
Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy or colonic TET tube
Sponsors
Jiangxi Provincial Cancer Hospital
The Second Hospital of Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response rate | 12 weeks | The clinical response rate at 8 weeks after fmt treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores of gastrointestinal symptoms | 4, 8, 12 weeks | Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0 |
| Change of toxicity grade | 4, 8, 12 weeks | The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4, 8, 12 weeks after FMT |
Countries
China
Contacts
Primary ContactFaming Zhang, MD; PHD
Outcome results
None listed