<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/NCT04424329</url>
  </required_header>
  <id_info>
    <org_study_id>19.17.NRC</org_study_id>
    <nct_id>NCT04424329</nct_id>
  </id_info>
  <brief_title>Effect of a Specific Blend of Fibers and Probiotics on the Microbiome</brief_title>
  <official_title>Effect of a Specific Blend of Fibers and Probiotics on the Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</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 study will investigate the effect of a mix of fibers and probiotics on faecal microbiota&#xD;
      challenged by an environmental stress&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Actual">September 25, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Minimizing microbiota composition change</measure>
    <time_frame>Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)</time_frame>
    <description>Shotgum metagenomics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increased intestinal microbiota diversity</measure>
    <time_frame>Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)</time_frame>
    <description>Measured by the Shannon diversity index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased microbiota gene richness</measure>
    <time_frame>Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)</time_frame>
    <description>Measured by gene counts from metagenome sequencing of the fecal microbiota</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut comfort</measure>
    <time_frame>Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)</time_frame>
    <description>Assessed each Gastrointestinal Symptoms (VOMITING, NAUSEA, AUDIBLE BOWEL SOUNDS, FLATULENCE, ABDOMINAL CRAMPS, BLOATING ) with a scale (from 0 to 10, 10 being the worst outcome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Microbiota Perturbation by an Environmental Challenge</condition>
  <arm_group>
    <arm_group_label>Nutrition intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ingestion of fibers and probiotics daily for 22 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fibers and probiotics</intervention_name>
    <description>A blend of fibers and seven probiotics</description>
    <arm_group_label>Nutrition intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Informed consent signed&#xD;
&#xD;
          2. Adult men and women aged 18 to 45 years&#xD;
&#xD;
          3. Healthy based on the medical screening visit and medical questionnaire&#xD;
&#xD;
          4. BMI in the range of 18.5 to 29.9 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known food allergy and intolerance&#xD;
&#xD;
          2. Currently participating in another clinical trial or research project&#xD;
&#xD;
          3. Fewer than 5 spontaneous bowel movements per week on average&#xD;
&#xD;
          4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times&#xD;
             daily&#xD;
&#xD;
          5. Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment&#xD;
&#xD;
          6. Medications or supplements that are known to alter gut function or microflora during&#xD;
             the 4 weeks prior to study enrolment&#xD;
&#xD;
          7. Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or&#xD;
             anticoagulant agents&#xD;
&#xD;
          8. Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or&#xD;
             herniotomy)&#xD;
&#xD;
          9. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols,&#xD;
             1 dl of red or white wine, or 3 dl of beer.&#xD;
&#xD;
         10. Artificially sweetened beverage intake higher than 1000 ml/ per day&#xD;
&#xD;
         11. Female subjects will be excluded if they are pregnant, gave birth in the last 6&#xD;
             months, or are lactating.&#xD;
&#xD;
         12. Subject having a hierarchical or family link with the research team members.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sami Damak</last_name>
    <role>Principal Investigator</role>
    <affiliation>Société des produits Nestlé</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Société des produits Nestlé/Metabolic Unit</name>
      <address>
        <city>Lausanne</city>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04424329
org study id: 19.17.NRC
nct id: NCT04424329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota
      challenged by an environmental stress
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Minimizing microbiota composition change
time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)
description: Shotgum metagenomics
measure: Increased intestinal microbiota diversity
time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
description: Measured by the Shannon diversity index
measure: Increased microbiota gene richness
time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
description: Measured by gene counts from metagenome sequencing of the fecal microbiota
measure: Gut comfort
time frame: Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)
description: Assessed each Gastrointestinal Symptoms (VOMITING, NAUSEA, AUDIBLE BOWEL SOUNDS, FLATULENCE, ABDOMINAL CRAMPS, BLOATING ) with a scale (from 0 to 10, 10 being the worst outcome)
arm group label: Nutrition intervention
arm group type: Experimental
description: Ingestion of fibers and probiotics daily for 22 days
arm group label: No intervention
arm group type: No Intervention
description: No intervention
intervention type: Dietary Supplement
intervention name: Fibers and probiotics
description: A blend of fibers and seven probiotics
arm group label: Nutrition intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sami Damak
role: Principal Investigator
affiliation: Société des produits Nestlé
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No