<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/NCT03027583</url>
  </required_header>
  <id_info>
    <org_study_id>HND-GI-023</org_study_id>
    <nct_id>NCT03027583</nct_id>
  </id_info>
  <brief_title>The Effect of Probiotic Intervention on Intestinal Permeability</brief_title>
  <official_title>The Effect of 6 Weeks Supplementation of Probiotic on Exercise-induced Intestinal Permeability in Trained Subjects - a Randomized, Double-blind, Placebo-controlled, Two Armed Parallel Group Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chr Hansen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atlantia Food Clinical Trials</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Signifikans ApS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chr Hansen</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>
      This trial is a single-site, randomised, double blind, placebo-controlled, two-armed&#xD;
      parallel-group trial in healthy adult volunteers. The trial will investigate the effect of&#xD;
      oral supplementation of a probiotic strain on the ability to attenuate exercise-induced&#xD;
      deterioration of intestinal barrier function and gastrointestinal symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial includes a run-in period of two weeks duration followed by a six weeks intervention&#xD;
      period.&#xD;
&#xD;
      After having given their written informed consent, subjects will complete screening&#xD;
      procedures to evaluate their eligibility for the trial and complete a run-in period of&#xD;
      minimum two weeks duration to washout possible pre-trial probiotics. At the screening visit&#xD;
      (visit 1), subjects will also perform a VO2max test on a running treadmill to determine their&#xD;
      individual VO2max.&#xD;
&#xD;
      After baseline assessments at visit 2 and 3, the subjects will be randomly assigned to one of&#xD;
      the two treatment groups (active or placebo product) in a ratio of 1:1. The two arms will be&#xD;
      stratified for gender.&#xD;
&#xD;
      The subjects will consume 1-2 capsules once daily, together with breakfast, for six weeks&#xD;
      starting at Day 1, the day after Visit 3. During the entire run-in and intervention period&#xD;
      the subjects will be asked not to consume any other probiotic products. During the entire&#xD;
      trial subjects should maintain their habitual life style in relation to physical activity&#xD;
      level, diet and sleep habits.&#xD;
&#xD;
      At Visit 2, 3, 4 and 5, the small intestinal permeability will be evaluated by the L:R ratio&#xD;
      measured in urine obtained 5 hours after oral ingestion of a lactulose and rhamnose solution.&#xD;
      The permeability test will be performed in combination with a 1 hour treadmill running&#xD;
      challenge when performed at Visit 3 and Visit 5. The treadmill run will be performed at a&#xD;
      velocity corresponding to 80% of the subjects individually measured VO2max.&#xD;
&#xD;
      Faecal, urine and blood samples will be collected at Visit 2, 3, 4 and 5 for evaluation of&#xD;
      the secondary objectives. The faecal samples collected will be: First bowel movement&#xD;
      post-permeability test at Visit 2, first bowel movement post-exercise test at Visit 3, first&#xD;
      bowel movement post-permeability test at Visit 4 and the first bowel movement post-exercise&#xD;
      at Visit 5.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in small intestine permeability</measure>
    <time_frame>6 weeks</time_frame>
    <description>The effect of 6 oral supplementation of a probiotic strain versus placebo on small intestinal permeability measured as the change in urinary lactulose:rhamnose ratio following a 1 hour exercise challenge.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">251</enrollment>
  <condition>Intestinal Permeability</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>63 subjects will be randomized to the experimental arm. The experimental product is a vegetable capsule containing a probiotic strain. Subjects will consume 1-2 capsules daily together with breakfast, equivalent to a dose of 50 bill CFU for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>63 subjects will be randomized to the placebo arm.The placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics. Subjects will consume 1-2 capsules daily with breakfast for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>6 weeks daily oral intake of a probiotic strain.</description>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>6 weeks daily oral intake of placebo.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent prior to any trial related procedures&#xD;
&#xD;
          2. Healthy (gastrointestinal symptoms are allowed, but not needed)&#xD;
&#xD;
          3. Weekly training load ≥ 4 hours within endurance sports as judged by the subject&#xD;
             (minimum 1.5 hours of the training must be running activity)&#xD;
&#xD;
          4. Able to complete a 10 km run on a treadmill within 60 minutes, as judged by the&#xD;
             subject&#xD;
&#xD;
          5. Willing to abstain from any probiotics products or medication known to alter&#xD;
             gastrointestinal function throughout the participation of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Abdominal surgery which, as judged by the investigator, might affect the&#xD;
             gastrointestinal function (except appendectomy and cholecystectomy)&#xD;
&#xD;
          2. Resting diastolic blood pressure ≥ 90 mmHg&#xD;
&#xD;
          3. Resting systolic blood pressure ≥ 140 mmHg&#xD;
&#xD;
          4. A current diagnosis of psychiatric disease&#xD;
&#xD;
          5. Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial&#xD;
             medication in the last 2 months&#xD;
&#xD;
          6. Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or&#xD;
             incidental use in the last 2 weeks prior to screening&#xD;
&#xD;
          7. Usage of medications, except contraceptives, in the last 2 weeks prior to screening&#xD;
&#xD;
          8. Diagnosed inflammatory gastrointestinal disease&#xD;
&#xD;
          9. Lactose intolerance&#xD;
&#xD;
         10. Any other disease that, by the Investigators discretion, could interfere with the&#xD;
             intestinal barrier function of the subject&#xD;
&#xD;
         11. Participation in other clinical trials in the past 2 months prior to screening&#xD;
&#xD;
         12. Regular use of probiotics in the last 2 months&#xD;
&#xD;
         13. Smoking and/or frequent use of other nicotine products&#xD;
&#xD;
         14. Desire and/or plans on changing current diet and/or exercise regime during the&#xD;
             participation of this trial&#xD;
&#xD;
         15. Use of laxatives, anti-diarrheals, anti-cholinergics within last 2 months prior to&#xD;
             screening&#xD;
&#xD;
         16. Use of immunosuppressant drugs within last 4 weeks prior to screening&#xD;
&#xD;
         17. Women: Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fergus Shanahan, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cork University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlantia Food Clinical trials</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</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/NCT03027583
org study id: HND-GI-023
nct id: NCT03027583
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is a single-site, randomised, double blind, placebo-controlled, two-armed
      parallel-group trial in healthy adult volunteers. The trial will investigate the effect of
      oral supplementation of a probiotic strain on the ability to attenuate exercise-induced
      deterioration of intestinal barrier function and gastrointestinal symptoms.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention
      period.

      After having given their written informed consent, subjects will complete screening
      procedures to evaluate their eligibility for the trial and complete a run-in period of
      minimum two weeks duration to washout possible pre-trial probiotics. At the screening visit
      (visit 1), subjects will also perform a VO2max test on a running treadmill to determine their
      individual VO2max.

      After baseline assessments at visit 2 and 3, the subjects will be randomly assigned to one of
      the two treatment groups (active or placebo product) in a ratio of 1:1. The two arms will be
      stratified for gender.

      The subjects will consume 1-2 capsules once daily, together with breakfast, for six weeks
      starting at Day 1, the day after Visit 3. During the entire run-in and intervention period
      the subjects will be asked not to consume any other probiotic products. During the entire
      trial subjects should maintain their habitual life style in relation to physical activity
      level, diet and sleep habits.

      At Visit 2, 3, 4 and 5, the small intestinal permeability will be evaluated by the L:R ratio
      measured in urine obtained 5 hours after oral ingestion of a lactulose and rhamnose solution.
      The permeability test will be performed in combination with a 1 hour treadmill running
      challenge when performed at Visit 3 and Visit 5. The treadmill run will be performed at a
      velocity corresponding to 80% of the subjects individually measured VO2max.

      Faecal, urine and blood samples will be collected at Visit 2, 3, 4 and 5 for evaluation of
      the secondary objectives. The faecal samples collected will be: First bowel movement
      post-permeability test at Visit 2, first bowel movement post-exercise test at Visit 3, first
      bowel movement post-permeability test at Visit 4 and the first bowel movement post-exercise
      at Visit 5.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in small intestine permeability
time frame: 6 weeks
description: The effect of 6 oral supplementation of a probiotic strain versus placebo on small intestinal permeability measured as the change in urinary lactulose:rhamnose ratio following a 1 hour exercise challenge.
arm group label: Probiotic
arm group type: Experimental
description: 63 subjects will be randomized to the experimental arm. The experimental product is a vegetable capsule containing a probiotic strain. Subjects will consume 1-2 capsules daily together with breakfast, equivalent to a dose of 50 bill CFU for 6 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: 63 subjects will be randomized to the placebo arm.The placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics. Subjects will consume 1-2 capsules daily with breakfast for 6 weeks.
intervention type: Dietary Supplement
intervention name: Probiotic
description: 6 weeks daily oral intake of a probiotic strain.
arm group label: Probiotic
intervention type: Dietary Supplement
intervention name: Placebo
description: 6 weeks daily oral intake of placebo.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fergus Shanahan, Professor
role: Principal Investigator
affiliation: Cork University Hospital
facility: 
country: Ireland
responsible party type: Sponsor
sharing ipd: No