<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/NCT04462601</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2019-01/RG-01</org_study_id>
    <nct_id>NCT04462601</nct_id>
  </id_info>
  <brief_title>Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity</brief_title>
  <acronym>IMISS</acronym>
  <official_title>Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      Gougerot-Sjögren syndrome or Sjögren syndrome is a chronic autoimmune disease belonging to&#xD;
      connectivitis, the classic triad of symptoms being the association of a sicca syndrome&#xD;
      (generally predominant in the mouth and / or ocular, but also present at the cutaneous,&#xD;
      vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. The study investigators&#xD;
      hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby&#xD;
      promoting microbial translocation, would have immunomodulatory effects that could be&#xD;
      correlated to changes in the activity of Gougerot-Sjögren disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 13, 2020</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in zonulin-1 levels from baseline in patients passing to a different level of disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in LPS-binding Protein levels from baseline in patients passing to a different level of disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>pg/ml, measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in LPS-binding Protein levels from baseline in patients reporting an improvement in disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>pg/ml, measured by ELISA; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in LPS-binding Protein levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>pg/ml, measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in soluble CD14 levels from baseline in patients passing to a different level of disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>ng/ml, measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in soluble CD14 levels from baseline in patients reporting an improvement in disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>ng/ml, measured by ELISA; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>ng/ml, measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in fungal 18s RNA levels from baseline in patients passing to a different level of disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>PCR and sequencing; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in fungal 18s RNA levels from baseline in patients reporting an improvement in disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>PCR and sequencing; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>PCR and sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in bacterial 16s RNA levels from baseline in patients passing to a different level of disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>PCR and sequencing; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in bacterial 16s RNA levels from baseline in patients reporting an improvement in disease activity</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>PCR and sequencing; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>PCR and sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>score 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L questionnaire</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>score 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality Of Life BREF questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>score 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality Of Life BREF questionnaire</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>score 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>score 0-42</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>score 0-42</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Fatigue Inventory</measure>
    <time_frame>Baseline</time_frame>
    <description>score 4-20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Fatigue Inventory</measure>
    <time_frame>Upon changing disease activity level (maximum 3 years)</time_frame>
    <description>score 4-20</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Sjogren's Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients with Sjögren Syndrome</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biomarker detection</intervention_name>
    <description>Quantification of serum markers of intestinal permeability and bacterial and fungal translocation</description>
    <arm_group_label>Patients with Sjögren Syndrome</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, blood, stool and saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients (≥ 18 years old) with primary Sjögren's syndrome according to the AECG&#xD;
        criteria and / or validation by an expert, subject to their agreement, followed in one of&#xD;
        the departments participating in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must be a member or beneficiary of a health insurance plan&#xD;
&#xD;
          -  Patients with primary Sjögren's syndrome according to the AECG criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is participating in a category I interventional study, or is in a period&#xD;
             of exclusion determined by a previous study&#xD;
&#xD;
          -  It is impossible to give the subject informed information&#xD;
&#xD;
          -  The patient is under safeguard of justice or state guardianship&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding patients&#xD;
&#xD;
          -  Patients with secondary Sjögren's syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Radjiv Goulabchand</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nimes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Radjiv Goulabchand</last_name>
    <phone>+33 (0)7.61.39.30.82</phone>
    <email>radjiv2001@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Nimes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anissa Megzari</last_name>
      <phone>04.66.68.42.36</phone>
      <email>drc@chu-nimes.fr</email>
    </contact>
    <investigator>
      <last_name>Radjiv Goulabchand</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jonathan Broner</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Erik Arnaud</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Philippe Lavigne</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Catherine Dunyach Remy</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04462601
org study id: NIMAO/2019-01/RG-01
nct id: NCT04462601
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gougerot-Sjögren syndrome or Sjögren syndrome is a chronic autoimmune disease belonging to
      connectivitis, the classic triad of symptoms being the association of a sicca syndrome
      (generally predominant in the mouth and / or ocular, but also present at the cutaneous,
      vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. The study investigators
      hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby
      promoting microbial translocation, would have immunomodulatory effects that could be
      correlated to changes in the activity of Gougerot-Sjögren disease.
observational model: Case-Only
time perspective: Prospective
measure: Difference in Intestinal Fatty Acid Binding Protein (I-FABP) levels from baseline in patients passing to a different level of disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
measure: Difference in zonulin-1 levels from baseline in patients passing to a different level of disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: ng/ml measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
measure: Difference in LPS-binding Protein levels from baseline in patients passing to a different level of disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: pg/ml, measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
measure: Difference in LPS-binding Protein levels from baseline in patients reporting an improvement in disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: pg/ml, measured by ELISA; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
measure: Difference in LPS-binding Protein levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
time frame: Upon changing disease activity level (maximum 3 years)
description: pg/ml, measured by ELISA
measure: Difference in soluble CD14 levels from baseline in patients passing to a different level of disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: ng/ml, measured by ELISA; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
measure: Difference in soluble CD14 levels from baseline in patients reporting an improvement in disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: ng/ml, measured by ELISA; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
measure: Difference in soluble CD14 levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
time frame: Upon changing disease activity level (maximum 3 years)
description: ng/ml, measured by ELISA
measure: Difference in fungal 18s RNA levels from baseline in patients passing to a different level of disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: PCR and sequencing; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
measure: Difference in fungal 18s RNA levels from baseline in patients reporting an improvement in disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: PCR and sequencing; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
measure: Difference in fungal 18s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
time frame: Upon changing disease activity level (maximum 3 years)
description: PCR and sequencing
measure: Difference in bacterial 16s RNA levels from baseline in patients passing to a different level of disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: PCR and sequencing; Change in disease activity levels defined by 3-point change on the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI)
measure: Difference in bacterial 16s RNA levels from baseline in patients reporting an improvement in disease activity
time frame: Upon changing disease activity level (maximum 3 years)
description: PCR and sequencing; patient-reported disease severity defined by 1-point increase on the European League Against Rheumatism Sjögren's syndrome Patient Reported Index (ESSPRI)
measure: Difference in bacterial 16s RNA levels between patients receiving or not systemic treatment (corticosteroids, plaquenil or methotrexate)
time frame: Upon changing disease activity level (maximum 3 years)
description: PCR and sequencing
measure: EQ-5D-5L questionnaire
time frame: Baseline
description: score 0-100
measure: EQ-5D-5L questionnaire
time frame: Upon changing disease activity level (maximum 3 years)
description: score 0-100
measure: World Health Organization Quality Of Life BREF questionnaire
time frame: Baseline
description: score 0-100
measure: World Health Organization Quality Of Life BREF questionnaire
time frame: Upon changing disease activity level (maximum 3 years)
description: score 0-100
measure: Hospital Anxiety and Depression Scale
time frame: Baseline
description: score 0-42
measure: Hospital Anxiety and Depression Scale
time frame: Upon changing disease activity level (maximum 3 years)
description: score 0-42
measure: Multidimensional Fatigue Inventory
time frame: Baseline
description: score 4-20
measure: Multidimensional Fatigue Inventory
time frame: Upon changing disease activity level (maximum 3 years)
description: score 4-20
arm group label: Patients with Sjögren Syndrome
intervention type: Other
intervention name: Biomarker detection
description: Quantification of serum markers of intestinal permeability and bacterial and fungal translocation
arm group label: Patients with Sjögren Syndrome
Plasma, blood, stool and saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Radjiv Goulabchand
role: Principal Investigator
affiliation: CHU Nimes
last name: Radjiv Goulabchand
phone: +33 (0)7.61.39.30.82
email: radjiv2001@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Syndrome