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Microbiota Transplantation for Radiation Enteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516461
Recruitment Status : Unknown
Verified October 2019 by Faming Zhang, The Second Hospital of Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : May 4, 2018
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
Fuzhou General Hospital
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Study Description
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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
Radiation Enteritis Procedure: Selective Microbiota Transplantation (SMT) Procedure: Fecal Microbiota Transplantation (FMT) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 7, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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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 Name: 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 Name: FMT


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Scores of gastrointestinal symptoms [ Time Frame: 4 weeks ]
    Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

  2. 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])


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516461


Contacts
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Contact: Faming Zhang, MD; PHD 086-25-58509883 fzhang@njmu.edu.cn

Locations
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China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883    fzhang@njmu.edu.cn   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fuzhou General Hospital
Investigators
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Principal Investigator: Faming Zhang, MD; PHD The Second Hospital of Nanjing Medical University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
Gut Microbiota
Radiation Enteritis
Selective Microbiota Transplantation
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases