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Microbiota Transplantation for Radiation Enteritis

Sponsor
The Second Hospital of Nanjing Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03516461
Collaborator
Fuzhou General Hospital (Other)
30
Enrollment
1
Location
2
Arms
34.8
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Selective Microbiota Transplantation (SMT)
  • Procedure: Fecal Microbiota Transplantation (FMT)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Selective Microbiota Transplantation and Fecal Microbiota Transplantation in Radiation Enteritis
Actual Study Start Date :
Jan 7, 2018
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of toxicity grade [4 weeks]

      The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4 weeks after SMT

    Secondary Outcome Measures

    1. Scores of gastrointestinal symptoms [4 weeks]

      Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

    2. Karnofsky Performance Status (KPS) scale [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])

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011

    Sponsors and Collaborators

    • The Second Hospital of Nanjing Medical University
    • Fuzhou General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT03516461
    Other Study ID Numbers:
    • SMT-YJ-201702
    First Posted:
    May 4, 2018
    Last Update Posted:
    Nov 1, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
    Gut Microbiota
    Radiation Enteritis
    Selective Microbiota Transplantation
    Fecal Microbiota Transplantation
    Additional relevant MeSH terms:
    Enteritis

    Study Results

    No Results Posted as of Nov 1, 2019