<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/NCT04447924</url>
  </required_header>
  <id_info>
    <org_study_id>HND-GI-038</org_study_id>
    <nct_id>NCT04447924</nct_id>
  </id_info>
  <brief_title>The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage</brief_title>
  <acronym>PIP-I</acronym>
  <official_title>The Effect of Daily Intake of Bifidobacterium Breve Bif195 on Small-intestinal Damage Induced by Ibuprofen - a Randomized, Double-blind, Placebo-controlled Trial in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chr Hansen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>
      To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of&#xD;
      small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule&#xD;
      endoscopy in a healthy US population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed,&#xD;
      parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the&#xD;
      effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to&#xD;
      daily intake of 800mg of Ibuprofen.&#xD;
&#xD;
      The trial includes a run-in period of two weeks duration followed by a six weeks intervention&#xD;
      period where Bif195/placebo and Ibuprofen is co-administered.&#xD;
&#xD;
      Subjects will participate in the trial for a total duration of 8 weeks including the run-in&#xD;
      phase. Besides the screening visit, the trial will consist of 5 visits.&#xD;
&#xD;
      After having given their written informed consent, subjects will complete the screening&#xD;
      procedures to evaluate their eligibility for participation in the trial and complete a run-in&#xD;
      period of two weeks duration to washout possible pre-trial probiotics and/or use of&#xD;
      medication. After baseline assessments at Visit 2, subjects will start daily intake of 800mg&#xD;
      of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo&#xD;
      product in a ratio of 1:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">June 10, 2021</completion_date>
  <primary_completion_date type="Actual">June 10, 2021</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>Lewis score area-under-the-curve for Bif195 vs Placebo</measure>
    <time_frame>6 weeks</time_frame>
    <description>The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">177</enrollment>
  <condition>Reduction of Small Intestinal Ulceration Risk</condition>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo arm. Similar trial product, but without Bif195 bacteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bif195 arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active trial product with minimum 15 billion CFU daily dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bif195</intervention_name>
    <description>Daily intake of Bif195 dietary supplement</description>
    <arm_group_label>Bif195 arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily intake of Placebo</description>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Healthy and without any gastrointestinal pain or other significant symptoms&#xD;
&#xD;
          -  Age 18 - 40 years&#xD;
&#xD;
          -  Willing to abstain from any other probiotic products and/or medication known to alter&#xD;
             gastrointestinal function throughout the participation of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eamonn Quigley, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Houston Methodist Gastroenterology Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlantia Food Clinical Trials</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</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>Ulcer</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/NCT04447924
org study id: HND-GI-038
nct id: NCT04447924
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of
      small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule
      endoscopy in a healthy US population.
This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed,
      parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the
      effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to
      daily intake of 800mg of Ibuprofen.

      The trial includes a run-in period of two weeks duration followed by a six weeks intervention
      period where Bif195/placebo and Ibuprofen is co-administered.

      Subjects will participate in the trial for a total duration of 8 weeks including the run-in
      phase. Besides the screening visit, the trial will consist of 5 visits.

      After having given their written informed consent, subjects will complete the screening
      procedures to evaluate their eligibility for participation in the trial and complete a run-in
      period of two weeks duration to washout possible pre-trial probiotics and/or use of
      medication. After baseline assessments at Visit 2, subjects will start daily intake of 800mg
      of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo
      product in a ratio of 1:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Lewis score area-under-the-curve for Bif195 vs Placebo
time frame: 6 weeks
description: The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Placebo arm. Similar trial product, but without Bif195 bacteria
arm group label: Bif195 arm
arm group type: Experimental
description: Active trial product with minimum 15 billion CFU daily dose
intervention type: Dietary Supplement
intervention name: Bif195
description: Daily intake of Bif195 dietary supplement
arm group label: Bif195 arm
intervention type: Other
intervention name: Placebo
description: Daily intake of Placebo
arm group label: Placebo arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eamonn Quigley, Professor
role: Principal Investigator
affiliation: Houston Methodist Gastroenterology Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ulcer
sharing ipd: No