<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/NCT03228589</url>
  </required_header>
  <id_info>
    <org_study_id>HND-GI-025</org_study_id>
    <nct_id>NCT03228589</nct_id>
  </id_info>
  <brief_title>The Effect of a Probiotic Strain on Aspirin-induced GI Damage.</brief_title>
  <acronym>PIP-D</acronym>
  <official_title>The Effect of 8 Weeks Intake of a Probiotic Strain on a 6 Week Aspirin-induced Intestinal Deterioration Challenge in Healthy Volunteers - 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>
  </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;
      daily intake of a probiotic strain versus placebo when co-administered to daily intake of&#xD;
      300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to&#xD;
      attenuate and/or reverse Aspirin-induced deterioration of the small intestine.&#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 where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks,&#xD;
      probiotic strain/placebo is given for two additional weeks to investigate the potential&#xD;
      effects of the probiotic strain on intestinal healing after long-time Aspirin use.&#xD;
&#xD;
      Subjects will participate in the trial for a total duration of 10 weeks including the run-in&#xD;
      phase. Besides the screening visit, the trial will consist of 6 visits.&#xD;
&#xD;
      After having given their written informed consent, subjects will complete 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 300mg&#xD;
      Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in&#xD;
      a ratio of 1:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2017</start_date>
  <completion_date type="Actual">April 4, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2017</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Aspirin challenge model</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lewis score from capsule endoscopy</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy Lewis score between Visit 2 (randomization) and Visit 7 (end of treatment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mucosal ulcer number</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal total ulcer number between Visit 2 (randomization) and Visit 7 (end of treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain module score of the GSRS questionnaire</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of pain module score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood I-FABP concentration</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 blood I-FABP concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total score of the GSRS questionnaire</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of total score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal red spots number</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal red spot number between Visit 2 (randomization) and Visit 7 (end of treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feces Calprotectin concentration.</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 feces Calprotectin concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood Calprotectin concentration</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the blood Calprotectin concentration between Visit 2 (randomization) and Visit 7 (end of treatment).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Side Effects of Acetylsalicylic Acid Use</condition>
  <arm_group>
    <arm_group_label>probiotic strain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active arm treated with the probiotic strain for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>probiotic strain</intervention_name>
    <description>8 weeks of treatment with probiotic strain</description>
    <arm_group_label>probiotic strain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>8 weeks of treatment</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Healthy and without any gastrointestinal discomfort/pain symptoms&#xD;
&#xD;
          -  Age ≥ 18 - ≤ 40 years of both gender (aim of 1/3 of each gender in each arm)&#xD;
&#xD;
          -  Sedentary lifestyle (weekly training load below 2 hours within endurance sports)&#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;
          -  Abdominal surgery which, as judged by the investigator, might affect the GI function&#xD;
             (except appendectomy and cholecystectomy)&#xD;
&#xD;
          -  History of peptic ulcer disease&#xD;
&#xD;
          -  Any known bleeding disorder&#xD;
&#xD;
          -  Allergy to Aspirin&#xD;
&#xD;
          -  History of H. pylori disease&#xD;
&#xD;
          -  Resting diastolic blood pressure ≥ 90 mmHg&#xD;
&#xD;
          -  Resting systolic blood pressure ≥ 140 mmHg&#xD;
&#xD;
          -  A current diagnosis of psychiatric disease&#xD;
&#xD;
          -  Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial&#xD;
             medication in the last 2 months&#xD;
&#xD;
          -  BMI &gt; 27&#xD;
&#xD;
          -  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 (Aspirin, Ibuprofen, Diclofenac,&#xD;
             Naproxen, Celecoxib, Mefenamic acid, Etoricoxib, Indometacin)&#xD;
&#xD;
          -  Usage of medications, except contraceptives, in the last 2 weeks prior to screening&#xD;
&#xD;
          -  Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Any other disease that, by the Investigators discretion, could interfere with the&#xD;
             intestinal barrier function of the subject&#xD;
&#xD;
          -  Participation in other clinical trials in the past 2 months prior to screening&#xD;
&#xD;
          -  Regular use of probiotics in the last 2 months&#xD;
&#xD;
          -  Smoking and/or frequent use of other nicotine products&#xD;
&#xD;
          -  Desire and/or plans on changing current diet and/or exercise regime during the&#xD;
             participation of this trial&#xD;
&#xD;
          -  Use of laxatives, anti-diarrheals, anti-cholinergics and PPI within last 2 months&#xD;
             prior to screening&#xD;
&#xD;
          -  Use of immunosuppressant drugs within last 4 weeks prior to screening&#xD;
&#xD;
          -  For Women: Pregnancy or lactation&#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>Martin Buckley, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>GI Physiology Laboratory, Mercy University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlantia Food Clnical Trials</name>
      <address>
        <city>Cork</city>
        <zip>T23 R50R</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 4, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 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/NCT03228589
org study id: HND-GI-025
nct id: NCT03228589
lead sponsor: 
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
      daily intake of a probiotic strain versus placebo when co-administered to daily intake of
      300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to
      attenuate and/or reverse Aspirin-induced deterioration of the small intestine.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention
      period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks,
      probiotic strain/placebo is given for two additional weeks to investigate the potential
      effects of the probiotic strain on intestinal healing after long-time Aspirin use.

      Subjects will participate in the trial for a total duration of 10 weeks including the run-in
      phase. Besides the screening visit, the trial will consist of 6 visits.

      After having given their written informed consent, subjects will complete 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 300mg
      Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in
      a ratio of 1:1.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Aspirin challenge model
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Lewis score from capsule endoscopy
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy Lewis score between Visit 2 (randomization) and Visit 7 (end of treatment).
measure: Mucosal ulcer number
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal total ulcer number between Visit 2 (randomization) and Visit 7 (end of treatment).
measure: Pain module score of the GSRS questionnaire
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of pain module score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).
measure: Blood I-FABP concentration
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 blood I-FABP concentration.
measure: Total score of the GSRS questionnaire
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of total score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).
measure: Mucosal red spots number
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal red spot number between Visit 2 (randomization) and Visit 7 (end of treatment).
measure: Feces Calprotectin concentration.
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 feces Calprotectin concentration.
measure: blood Calprotectin concentration
time frame: 8 weeks
description: The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the blood Calprotectin concentration between Visit 2 (randomization) and Visit 7 (end of treatment).
arm group label: probiotic strain
arm group type: Experimental
description: Active arm treated with the probiotic strain for 8 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks.
intervention type: Dietary Supplement
intervention name: probiotic strain
description: 8 weeks of treatment with probiotic strain
arm group label: probiotic strain
intervention type: Dietary Supplement
intervention name: Placebo
description: 8 weeks of treatment
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Buckley, Dr
role: Principal Investigator
affiliation: GI Physiology Laboratory, Mercy University Hospital
facility: 
country: Ireland
responsible party type: Sponsor
sharing ipd: No