Microbiota Transplantation for Radiation Enteritis

October 30, 2019 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selective Microbiota Transplant (SMT)
Patients undergo once SMT a day for three consecutive days.
Procedure: Selective Microbiota Transplantation (SMT)
Selective microbiota transplantation for patients via nasointestinal tube (once per day for 3 days)
Other Names:
  • SMT
Experimental: Fecal Microbiota Transplantation (FMT)
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)
Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy (once per day and no more than 3 times)
Other Names:
  • FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of toxicity grade
Time Frame: 4 weeks
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
Time Frame: 4 weeks
Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0
4 weeks
Karnofsky Performance Status (KPS) scale
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Collaborators

Fuzhou General Hospital

Investigators

  • Principal Investigator: Faming Zhang, MD; PHD, The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 7, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMT-YJ-201702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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