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Relationship Between "FODMAPs" and "GVHD"

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04660487
Collaborator
(none)
100
Enrollment
1
Location
48
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With the stem cell transplanting increasing, patients which effected with "GVHD" were also increased. To evaluation the relationship between "FODMAPs" and "GVHD", Bone marrow transplant patients were recruited.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The feces were collected from the patients who had been successfully transplanted after bone marrow transplantation. After 24 hours of culture in the culture medium, the degradation rate of "FODMAPs" was detected, and the relationship between the degradation rate and the occurrence time and degree of "GVHD" was observed

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Relationship Between the Utilization and Degradation Rate of "FODMAPs" by Intestinal Flora and "GVHD"
    Actual Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of GVHD [90 days]

      The occurrence time and degree of GVHD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Clinical diagnosis of "AML","ALL","MDS" or "MM" Disease;

    2. Must be treated with bone marrow transplantation;

    3. The transplanted bone marrow was successfully planted

    Exclusion Criteria:

    1. Gastrointestinal diseases；

    2. Age>60; or Age<10；

    3. Probiotics or prebiotics were taken before enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 中国 Suzhou Jiangsu China 215006

    Sponsors and Collaborators

    • The First Affiliated Hospital of Soochow University

    Investigators

    • Study Chair: Depei Wu, SOOCHOW UNIV

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qi Xiao-Fei, Dean, The First Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT04660487
    Other Study ID Numbers:
    • FODMAPS202001
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Mar 29, 2022