<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/NCT04448847</url>
  </required_header>
  <id_info>
    <org_study_id>HND-GI-036</org_study_id>
    <nct_id>NCT04448847</nct_id>
  </id_info>
  <brief_title>Mapping the MoA Behind GI Protection From Bif195</brief_title>
  <acronym>PIP-M</acronym>
  <official_title>Discovering the Mechanisms of Action for the In-vivo Protection of Aspirin-induced Enteropathy by Bifidobacterium Breve Bif195 in Man - a Randomised, Double-blinded, Placebo-controlled, Cross-over 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>
      The trial will investigate effects of daily intake of the bacterial strain Bif195 or placebo&#xD;
      when co-administered to once-daily oral intake of 300 mg of Acetylsalicylic Acid (ASA).&#xD;
&#xD;
      The trial includes a run-in period of two weeks duration followed by a 4-week intervention&#xD;
      period in which Bif195/placebo and ASA are co-administered. This period is followed by a&#xD;
      6-week wash-out period before a new 4-week period is performed with a cross-over&#xD;
      Bif195/placebo intervention as well as ASA co-administration. Bif195 and placebo&#xD;
      interventions are performed double-blinded in randomised order in a cross-over fashion for&#xD;
      each subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will participate in the trial for a total duration of approximately 17 weeks&#xD;
      including the run-in phase. Besides the screening visit, the trial will consist of 4 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. On the morning of day 4 after baseline assessments at Visit 2, all subjects will&#xD;
      start daily intake of 300 mg ASA in combination with Bif195 or placebo in a ratio of 1:1&#xD;
      according to the randomisation performed at Visit 2.&#xD;
&#xD;
      At visit 2 - 5, all subjects will be biopsied from the upper small intestine and the&#xD;
      ventricle during a gastroscopy procedure. At each of these 4 visits, 6 biopsies will be taken&#xD;
      from pre-specified locations in the duodenum and 2 biopsies will be taken from the ventricle&#xD;
      (approximately 5 mg each). Luminal fluids will also be collected during the gastroscopy&#xD;
      (approximately 2 ml per visit). One venous blood sample (of 20 ml per visit) will also be&#xD;
      collected at each of these visits.&#xD;
&#xD;
      The analysis on biopsies and luminal fluid samples will include a combination of&#xD;
      transcriptomic, microbiome, proteomics and metabolomics analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">January 12, 2021</completion_date>
  <primary_completion_date type="Actual">January 12, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>a randomised, double-blinded, placebo-controlled, cross-over trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The effects of daily intake of Bif195 versus placebo</measure>
    <time_frame>before vs after 4 week intervention</time_frame>
    <description>Lanza Score obtained during endoscopy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</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 100 billion CFU daily dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bif195</intervention_name>
    <description>Active trial product with minimum 100 billion CFU daily dose</description>
    <arm_group_label>Bif195 arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo similar to trial product but without Bif195</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 discomfort/pain or other significant&#xD;
                  symptoms&#xD;
&#xD;
               -  Age ≥ 18 and ≤ 40 years&#xD;
&#xD;
               -  Willing to abstain from any other probiotic products and/or medication known to&#xD;
                  alter 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>Filip Knop, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Clinical Metabolic Research, Gentofte Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Clinical Metabolic Research, Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2023</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 26, 2020</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04448847/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04448847/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04448847
org study id: HND-GI-036
nct id: NCT04448847
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial will investigate effects of daily intake of the bacterial strain Bif195 or placebo
      when co-administered to once-daily oral intake of 300 mg of Acetylsalicylic Acid (ASA).

      The trial includes a run-in period of two weeks duration followed by a 4-week intervention
      period in which Bif195/placebo and ASA are co-administered. This period is followed by a
      6-week wash-out period before a new 4-week period is performed with a cross-over
      Bif195/placebo intervention as well as ASA co-administration. Bif195 and placebo
      interventions are performed double-blinded in randomised order in a cross-over fashion for
      each subject.
Subjects will participate in the trial for a total duration of approximately 17 weeks
      including the run-in phase. Besides the screening visit, the trial will consist of 4 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. On the morning of day 4 after baseline assessments at Visit 2, all subjects will
      start daily intake of 300 mg ASA in combination with Bif195 or placebo in a ratio of 1:1
      according to the randomisation performed at Visit 2.

      At visit 2 - 5, all subjects will be biopsied from the upper small intestine and the
      ventricle during a gastroscopy procedure. At each of these 4 visits, 6 biopsies will be taken
      from pre-specified locations in the duodenum and 2 biopsies will be taken from the ventricle
      (approximately 5 mg each). Luminal fluids will also be collected during the gastroscopy
      (approximately 2 ml per visit). One venous blood sample (of 20 ml per visit) will also be
      collected at each of these visits.

      The analysis on biopsies and luminal fluid samples will include a combination of
      transcriptomic, microbiome, proteomics and metabolomics analysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: a randomised, double-blinded, placebo-controlled, cross-over trial
measure: The effects of daily intake of Bif195 versus placebo
time frame: before vs after 4 week intervention
description: Lanza Score obtained during endoscopy
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 100 billion CFU daily dose
intervention type: Dietary Supplement
intervention name: Bif195
description: Active trial product with minimum 100 billion CFU daily dose
arm group label: Bif195 arm
intervention type: Other
intervention name: Placebo
description: Placebo similar to trial product but without Bif195
arm group label: Placebo arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Filip Knop, Professor
role: Principal Investigator
affiliation: Center for Clinical Metabolic Research, Gentofte Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Ulcer
sharing ipd: No
provided document: 
provided document: 