Microbiota Transplantation for Radiation Enteritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Radiation Enteritis

Intervention / Treatment
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* Procedure: Selective Microbiota Transplantation (SMT)
* Procedure: Fecal Microbiota Transplantation (FMT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective Microbiota Transplant (SMT)<br>Patients undergo once SMT a day for three consecutive days. | Procedure: Selective Microbiota Transplantation (SMT)<br>* Selective microbiota transplantation for patients via nasointestinal tube (once per day for 3 days)<br>* Other names: SMT;|
| Experimental: Fecal Microbiota Transplantation (FMT)<br>Patients undergo FMT on day 1. If they fail to benefit from single FMT, repeat FMTs (no more than 3 times) would be performed. | Procedure: Fecal Microbiota Transplantation (FMT)<br>* Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy (once per day and no more than 3 times)<br>* Other names: FMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of toxicity grade | The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4 weeks after SMT | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of gastrointestinal symptoms | Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0 | 4 weeks | 
| Karnofsky Performance Status (KPS) scale | 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]) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microbiota, Radiation Enteritis, Selective Microbiota Transplantation, Fecal Microbiota Transplantation