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The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

Primary Purpose

Ulcerative Colitis, Fecal Microbiota Transplantation

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
Jun Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

25 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • mild to moderate UC patients
  • male
  • volunteered to our FMT trial

Exclusion Criteria:

  • severe UC
  • Hb < 6g/dL

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ulcerative Colitis

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change of mayo criteria in UC patients after FMT.
    Number of patients with adverse events after FMT.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 23, 2015
    Last Updated
    May 5, 2015
    Sponsor
    Jun Liu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02435160
    Brief Title
    The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jun Liu

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis, Fecal Microbiota Transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ulcerative Colitis
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Fecal Microbiota Transplantation
    Primary Outcome Measure Information:
    Title
    Change of mayo criteria in UC patients after FMT.
    Time Frame
    one year
    Title
    Number of patients with adverse events after FMT.
    Time Frame
    one year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: mild to moderate UC patients male volunteered to our FMT trial Exclusion Criteria: severe UC Hb < 6g/dL

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35962454
    Citation
    Huang C, Huang Z, Ding L, Fu Y, Fan J, Mei Q, Lou L, Wang J, Yin N, Lu Y, Guo S, Zeng Y. Fecal microbiota transplantation versus glucocorticoids for the induction of remission in mild to moderate ulcerative colitis. J Transl Med. 2022 Aug 12;20(1):354. doi: 10.1186/s12967-022-03569-3.
    Results Reference
    derived

    Learn more about this trial

    The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

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