<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/NCT01666717</url>
  </required_header>
  <id_info>
    <org_study_id>ML4355_VOC</org_study_id>
    <nct_id>NCT01666717</nct_id>
  </id_info>
  <brief_title>Characterization of Disease Related Changes in Inflammatory Bowel Disease Using Fecal Metabolite Profiling</brief_title>
  <official_title>Characterization of Disease Related Changes in Inflammatory Bowel Disease Using Fecal Metabolite Profiling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel&#xD;
      Disease(IBD) patients versus healthy controls (HC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2008</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Healthy controls (HC)</arm_group_label>
    <description>HC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inflammatory Bowel Disease (IBD) patients</arm_group_label>
    <description>Crohn's disease (CD), Ulcerative colitis (UC) and pouchitis</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fecal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of IBD&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of antibiotics in the preceding month&#xD;
&#xD;
          -  Intake of pre- or probiotics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>KULeuven-UZLeuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Kristin Verbeke</investigator_full_name>
    <investigator_title>Professor K. Verbeke</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01666717
org study id: ML4355_VOC
nct id: NCT01666717
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel
      Disease(IBD) patients versus healthy controls (HC).
observational model: Case-Control
time perspective: Retrospective
arm group label: Healthy controls (HC)
description: HC
arm group label: Inflammatory Bowel Disease (IBD) patients
description: Crohn's disease (CD), Ulcerative colitis (UC) and pouchitis
Fecal samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Kristin Verbeke
investigator title: Professor K. Verbeke
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases