xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998174</url>
    </required_header>
    <id_info>
      <org_study_id>FMT for MC</org_study_id>
      <nct_id>NCT05998174</nct_id>
    </id_info>
    <brief_title>Faecal Microbiota Transplantation for Microscopic Colitis</brief_title>
    <official_title>Faecal Microbiota Transplantation for Microscopic Colitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hvidovre University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hvidovre University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A pilot study investigating if orally administrated faecal microbiota transplantation&#xD;
        capsules have the potential to treat active microscopic colitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>pilot trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment effect</measure>
      <time_frame>3 weeks</time_frame>
      <description>Proportion of participants in remission</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Microscopic Colitis</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Faecal Microbiota Transplantation</intervention_name>
      <description>treatment with capsules</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of microscopic colitis&#xD;
  &#xD;
            -  Date of diagnosis/histological confirmation &lt; 12 months&#xD;
  &#xD;
            -  Active disease according to Hjortswang's criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with ulcerative colitis or Crohn's disease&#xD;
  &#xD;
            -  Diagnosed with celiac disease&#xD;
  &#xD;
            -  Active gastrointestinal infection&#xD;
  &#xD;
            -  Previous bowel resection of bowel (except appendectomy)&#xD;
  &#xD;
            -  Previous cholecystectomy&#xD;
  &#xD;
            -  Treatment with systemic steroid within 4 weeks, including budesonide&#xD;
  &#xD;
            -  Antibiotics 3 months prior&#xD;
  &#xD;
            -  Severe immunodeficiency,&#xD;
  &#xD;
            -  Pregnancy, planned pregnancy and breastfeeding&#xD;
  &#xD;
            -  Treatment with constipants such as psyllium, loperamide, bile binders, opium drops or&#xD;
               codeine up to 2 weeks before inclusion and during participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
      <investigator_full_name>Sigen Wildt</investigator_full_name>
      <investigator_title>Consultant, MD, ph.d</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colitis</mesh_term>
      <mesh_term>Colitis, Microscopic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998174
  org study id: FMT for MC
  nct id: NCT05998174
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A pilot study investigating if orally administrated faecal microbiota transplantation
        capsules have the potential to treat active microscopic colitis.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: pilot trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Treatment effect
  time frame: 3 weeks
  description: Proportion of participants in remission
  intervention type: Other
  intervention name: Faecal Microbiota Transplantation
  description: treatment with capsules
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Hvidovre University Hospital
  investigator full name: Sigen Wildt
  investigator title: Consultant, MD, ph.d
  mesh term: Colitis
  mesh term: Colitis, Microscopic
  sharing ipd: No