<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/NCT03797937</url>
  </required_header>
  <id_info>
    <org_study_id>2018BDM2</org_study_id>
    <nct_id>NCT03797937</nct_id>
  </id_info>
  <brief_title>Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II</brief_title>
  <official_title>Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National MS Center Melsbroek</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National MS Center Melsbroek</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this longitudinal study is to (1) explore the association between the gut&#xD;
      microbiota and inflammatory disease activity in early onset multiple sclerosis, (2)&#xD;
      investigate whether/how gut microbial composition vary when patients experience a relapse,&#xD;
      and (3) to assess whether the gut microbiota shows increased similarities between affected&#xD;
      pairs of first-degree relatives within the same family when compared with discordant pairs of&#xD;
      first-degree relatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using metagenomics, as well as clinical, immunological, and radiological observations, the&#xD;
      investigators will investigate if active relapsing-remitting multiple sclerosis patients have&#xD;
      a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less&#xD;
      active disease and matched healthy controls.&#xD;
&#xD;
      More specifically, the investigators will investigate whether temporal variability of the gut&#xD;
      microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes&#xD;
      in the gut microbiota are predictive of future inflammatory disease activity in multiple&#xD;
      sclerosis, and whether gut microbiota characteristics are predictive of the disease course&#xD;
      after 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical evidence for active disease</measure>
    <time_frame>3 years</time_frame>
    <description>Time to first relapse (after baseline) will be reported for all patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological evidence for active disease</measure>
    <time_frame>3 years</time_frame>
    <description>Occurrence of new contrast-enhancing T1 hyper intense lesions, or changes in white matter lesion volume (i.e. new or enlarging T2 hyper intense lesions)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple sclerosis (MS) patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple sclerosis (MS) patients undergoing a relapse</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple sclerosis (MS) patients from multiplex MS families</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic resonance imaging (MRI)</intervention_name>
    <description>MRI scanner</description>
    <arm_group_label>Multiple sclerosis (MS) patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria patients:&#xD;
&#xD;
          -  Diagnosis of MS (as defined by the 2010 McDonald criteria).&#xD;
&#xD;
          -  Occurrence of symptoms no longer than 5 years before baseline.&#xD;
&#xD;
          -  Aged 18-65.&#xD;
&#xD;
          -  Willingness to participate in the study and to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria patients:&#xD;
&#xD;
          -  Treatment with high doses of systemic steroids 2 months before baseline.&#xD;
&#xD;
          -  Use of antibiotics 3 months before baseline.&#xD;
&#xD;
          -  Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer).&#xD;
&#xD;
          -  Other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type&#xD;
             1 and 2, psoriasis).&#xD;
&#xD;
        Additional inclusion criteria for MS patients undergoing a relapse:&#xD;
&#xD;
        • Ability to provide a faecal sample within 4 weeks from onset of the first symptoms&#xD;
        suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical&#xD;
        sign or clinical worsening of a previous sign/symptom persisting for &gt;=24 hours in the&#xD;
        absence of fever.&#xD;
&#xD;
        Additional exclusion criteria for MS patients undergoing a relapse:&#xD;
&#xD;
          -  Treatment with cortisone before collection of baseline faecal sample.&#xD;
&#xD;
          -  Evidence of a relapse less than 2 months before baseline.&#xD;
&#xD;
          -  Switching disease modifying treatment less than 2 months before baseline.&#xD;
&#xD;
        Inclusion criteria healthy controls:&#xD;
&#xD;
          -  Willingness to participate to the study and to sign the informed consent.&#xD;
&#xD;
          -  Aged &gt;=18.&#xD;
&#xD;
        Exclusion criteria healthy controls:&#xD;
&#xD;
          -  Neurodegenerative disorders.&#xD;
&#xD;
          -  Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer) or&#xD;
             autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1, psoriasis).&#xD;
&#xD;
          -  Use of antibiotics 3 months before baseline.&#xD;
&#xD;
          -  Treatment with high doses of systemic steroids 2 months before baseline.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie D'hooghe, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National MS Center Melsbroek</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Jette</city>
        <state>Brussel</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationaal Multiple Sclerose Centrum Melsbroek</name>
      <address>
        <city>Melsbroek</city>
        <state>Vlaams-Brabant</state>
        <zip>1820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>March 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National MS Center Melsbroek</investigator_affiliation>
    <investigator_full_name>Marie D'hooghe</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03797937
org study id: 2018BDM2
nct id: NCT03797937
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this longitudinal study is to (1) explore the association between the gut
      microbiota and inflammatory disease activity in early onset multiple sclerosis, (2)
      investigate whether/how gut microbial composition vary when patients experience a relapse,
      and (3) to assess whether the gut microbiota shows increased similarities between affected
      pairs of first-degree relatives within the same family when compared with discordant pairs of
      first-degree relatives.
Using metagenomics, as well as clinical, immunological, and radiological observations, the
      investigators will investigate if active relapsing-remitting multiple sclerosis patients have
      a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less
      active disease and matched healthy controls.

      More specifically, the investigators will investigate whether temporal variability of the gut
      microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes
      in the gut microbiota are predictive of future inflammatory disease activity in multiple
      sclerosis, and whether gut microbiota characteristics are predictive of the disease course
      after 2 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Clinical evidence for active disease
time frame: 3 years
description: Time to first relapse (after baseline) will be reported for all patients.
measure: Radiological evidence for active disease
time frame: 3 years
description: Occurrence of new contrast-enhancing T1 hyper intense lesions, or changes in white matter lesion volume (i.e. new or enlarging T2 hyper intense lesions)
arm group label: Multiple sclerosis (MS) patients
arm group type: Experimental
description: Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
arm group label: Healthy controls
arm group type: No Intervention
description: Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
arm group label: Multiple sclerosis (MS) patients undergoing a relapse
arm group type: No Intervention
description: Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
arm group label: Multiple sclerosis (MS) patients from multiplex MS families
arm group type: No Intervention
description: Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
intervention type: Other
intervention name: Magnetic resonance imaging (MRI)
description: MRI scanner
arm group label: Multiple sclerosis (MS) patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marie D'hooghe, M.D.
role: Principal Investigator
affiliation: National MS Center Melsbroek
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: National MS Center Melsbroek
investigator full name: Marie D'hooghe
investigator title: Prof. Dr.
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No