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Faecal Microbiota Transplantation for Microscopic Colitis

Primary Purpose

Microscopic Colitis

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Faecal Microbiota Transplantation
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microscopic Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of microscopic colitis Date of diagnosis/histological confirmation < 12 months Active disease according to Hjortswang's criteria Exclusion Criteria: Diagnosed with ulcerative colitis or Crohn's disease Diagnosed with celiac disease Active gastrointestinal infection Previous bowel resection of bowel (except appendectomy) Previous cholecystectomy Treatment with systemic steroid within 4 weeks, including budesonide Antibiotics 3 months prior Severe immunodeficiency, Pregnancy, planned pregnancy and breastfeeding Treatment with constipants such as psyllium, loperamide, bile binders, opium drops or codeine up to 2 weeks before inclusion and during participation

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Treatment effect
    Proportion of participants in remission

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Hvidovre University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05998174
    Brief Title
    Faecal Microbiota Transplantation for Microscopic Colitis
    Official Title
    Faecal Microbiota Transplantation for Microscopic Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hvidovre University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Microscopic Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    pilot trial
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Faecal Microbiota Transplantation
    Intervention Description
    treatment with capsules
    Primary Outcome Measure Information:
    Title
    Treatment effect
    Description
    Proportion of participants in remission
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of microscopic colitis Date of diagnosis/histological confirmation < 12 months Active disease according to Hjortswang's criteria Exclusion Criteria: Diagnosed with ulcerative colitis or Crohn's disease Diagnosed with celiac disease Active gastrointestinal infection Previous bowel resection of bowel (except appendectomy) Previous cholecystectomy Treatment with systemic steroid within 4 weeks, including budesonide Antibiotics 3 months prior Severe immunodeficiency, Pregnancy, planned pregnancy and breastfeeding Treatment with constipants such as psyllium, loperamide, bile binders, opium drops or codeine up to 2 weeks before inclusion and during participation

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Faecal Microbiota Transplantation for Microscopic Colitis

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