<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/NCT04421313</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL17_0397</org_study_id>
    <nct_id>NCT04421313</nct_id>
  </id_info>
  <brief_title>Fibres Supplementation in Rheumatoid Arthritis</brief_title>
  <acronym>SUPER-FIBRES</acronym>
  <official_title>Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Génétique Moléculaire de Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with&#xD;
      either fiber supplements or placebo.&#xD;
&#xD;
      Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes :&#xD;
      variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and&#xD;
      B cells, Th17) and heart-rate variability.&#xD;
&#xD;
      Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate&#xD;
      disease activity will be recruited in each arm and 29 controls with mechanic disease&#xD;
      (osteoarthritis, tendinitis).&#xD;
&#xD;
      Collection: Blood, feces, disease activity and heart rate variability will be collected at&#xD;
      baseline and week 4.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Short-chain fatty acid (SCFA)</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the gut microbiota bacteria</measure>
    <time_frame>36 months</time_frame>
    <description>Amplification of the V1-V3 bacterial region targeting 16S bacterial ribosomal RNA and sequencing by Mi-sequencer will be performed. Then, a bioinformatics analysis will be done using the QIIME software and the composition of the intestinal flora will be analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of immune cells (regulatory T and B cells, Th17)</measure>
    <time_frame>36 months</time_frame>
    <description>Flow cytometric determination of immune cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of heart-rate variability.</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">87</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Rhumatoid Arthritis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Subjects</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dietary Fiber Supplementation</intervention_name>
    <description>12 g of inulin or of maltodextrin in powder, to dilute in water once daily, during 1 month. Given in pre-weighted pots (one pot per day, similar color and aspect)</description>
    <arm_group_label>Control Subjects</arm_group_label>
    <arm_group_label>Rhumatoid Arthritis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Aged 18 to 85&#xD;
&#xD;
          -  Be affiliated to or beneficiary of a French social security scheme&#xD;
&#xD;
          -  o No desire for pregnancy for the duration of the study (Effective contraception for&#xD;
             women of reproductive age, for the duration of the study (surgical sterilization,&#xD;
             hormonal contraceptives, barrier method, intrauterine device))&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Lack of written informed consent after a period of reflection&#xD;
&#xD;
          -  Patient involved in other research or research for which the exclusion period has not&#xD;
             ended&#xD;
&#xD;
          -  Pregnant or nursing woman&#xD;
&#xD;
          -  Type I or II diabetes&#xD;
&#xD;
          -  Patient receiving more than 10 mg/d corticosteroids at time of inclusion&#xD;
&#xD;
          -  Patient who received corticosteroid infusions in the month prior to randomization&#xD;
&#xD;
          -  Unusual consumption (&gt;50% higher than usual consumption) of dietary fibre in the last&#xD;
             72 hours (assessed by food questionnaire)&#xD;
&#xD;
        Patient with Rheumatoid polyarthritis&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis meeting ACR/EULAR 2010 criteria&#xD;
&#xD;
          -  With moderate clinical activity: DAS28-CRP 3.2 and 5.1&#xD;
&#xD;
          -  Patient receiving conventional background treatment at stable doses and should not be&#xD;
             modified during 4-week follow-up&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient treated by targeted RA treatment in the year prior to inclusion&#xD;
&#xD;
          -  Patient who received antibiotic therapy within 3 months prior to randomization&#xD;
&#xD;
        Control subjects&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Patient consulting in the rheumatology department for a mechanical pathology:&#xD;
             osteoarthritis of the limbs or spine, osteoporosis, tendinopathy, fibromyalgia,&#xD;
             algodystrophy or capsulitis.&#xD;
&#xD;
          -  Matched to a gender and age PR topic 5 years&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        · Patient with autoimmune disease, infection or progressive cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire DAIEN</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU of Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claire DAIEN, MD-PhD</last_name>
    <phone>467332319</phone>
    <phone_ext>+33</phone_ext>
    <email>c-daien@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>UH Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire DAIEN</last_name>
      <email>c-daien@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>dietary fibre</keyword>
  <keyword>gut-microbiota</keyword>
  <keyword>SCFAs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT04421313
org study id: RECHMPL17_0397
nct id: NCT04421313
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with
      either fiber supplements or placebo.

      Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes :
      variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and
      B cells, Th17) and heart-rate variability.

      Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate
      disease activity will be recruited in each arm and 29 controls with mechanic disease
      (osteoarthritis, tendinitis).

      Collection: Blood, feces, disease activity and heart rate variability will be collected at
      baseline and week 4.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evaluation of Short-chain fatty acid (SCFA)
time frame: 36 months
measure: Description of the gut microbiota bacteria
time frame: 36 months
description: Amplification of the V1-V3 bacterial region targeting 16S bacterial ribosomal RNA and sequencing by Mi-sequencer will be performed. Then, a bioinformatics analysis will be done using the QIIME software and the composition of the intestinal flora will be analyzed.
measure: Description of immune cells (regulatory T and B cells, Th17)
time frame: 36 months
description: Flow cytometric determination of immune cells
measure: Evaluation of heart-rate variability.
time frame: 36 months
arm group label: Rhumatoid Arthritis
arm group type: Experimental
description: The patients with Rheumatoid arthritis receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
arm group label: Control Subjects
arm group type: Placebo Comparator
description: The patients with Control Subjects receive 12 g/day of INULIN or 10,5g/day of maltodextrine during 30 days
intervention type: Drug
intervention name: Dietary Fiber Supplementation
description: 12 g of inulin or of maltodextrin in powder, to dilute in water once daily, during 1 month. Given in pre-weighted pots (one pot per day, similar color and aspect)
arm group label: Control Subjects
arm group label: Rhumatoid Arthritis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Claire DAIEN
role: Principal Investigator
affiliation: CHU of Montpellier
last name: Claire DAIEN, MD-PhD
phone: 467332319
phone ext: +33
email: c-daien@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid