<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/NCT03015441</url>
  </required_header>
  <id_info>
    <org_study_id>NU378</org_study_id>
    <nct_id>NCT03015441</nct_id>
  </id_info>
  <brief_title>Evaluation of a 28-day Fermented Milk Product Consumption Twice Daily as Compared to a Non-fermented Milk Product on Intestinal Gas Production in Healthy Subjects High Dihydrogen Producers</brief_title>
  <acronym>BREEZE</acronym>
  <official_title>Evaluation of a 28-day Fermented Milk Product Consumption Twice Daily as Compared to a Non-fermented Milk Product on Intestinal Gas Production in Healthy Subjects High Dihydrogen Producers A Randomized, Controlled, Double-blind, Parallel Arms, Adaptive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danone Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danone Research</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to assess the effect of a 28-day fermented milk product&#xD;
      consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in&#xD;
      healthy subjects high H2 producers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">June 21, 2017</completion_date>
  <primary_completion_date type="Actual">May 4, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between groups of the change from baseline (Day0) of breath H2 production elicited by a lactulose challenge test after 28 days of investigational product consumption</measure>
    <time_frame>Baseline and after 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between groups of the change from baseline (Day0) of breath H2 production elicited by a lactulose challenge test after 14 days of investigational product consumption</measure>
    <time_frame>Baseline and after 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between groups of the change from baseline (Day0) of breath CH4 production elicited by a lactulose challenge test after 14 days and 28 days of investigational product consumption</measure>
    <time_frame>Baseline, after 14 days and after 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between groups of the change from baseline (Day0) in the fasting breath H2 and CH4 values after 14 days and 28 days of investigational product consumption</measure>
    <time_frame>Baseline, after 14 days and after 28 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Comparison between groups of the change in composition and activity of gut microbiota from stool samples collected before and after 28 days of investigational product consumption</measure>
    <time_frame>Baseline, after 28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse event</measure>
    <time_frame>AE and SAE assessment through study completion and up to 14 days after the last study visit</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Excessive Intestinal Gas Production</condition>
  <arm_group>
    <arm_group_label>Arm 1: Fermented milk product containing probiotics</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Milk-based non-fermented dairy product</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Milk product fermented by lactic bacteria or not fermented</intervention_name>
    <description>2 pots of 125g consumed daily during 28 days</description>
    <arm_group_label>Arm 1: Fermented milk product containing probiotics</arm_group_label>
    <arm_group_label>Arm 2: Milk-based non-fermented dairy product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with body mass index (BMI) between 18.0 and 30.0 kg/m2 (bounds excluded)&#xD;
&#xD;
          -  Subjects having a high dihydrogen (H2) production as defined by a fasting exhaled&#xD;
             level of H2 in breath at 10 parts per million (ppm) or more.&#xD;
&#xD;
          -  Women of childbearing potential must be using a medically approved method of&#xD;
             contraception OR women must be postmenopausal for at least 12 months prior to study&#xD;
             entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with functional gastrointestinal disorder according to ROME III criteria&#xD;
             (Functional Bowel Disorders/FBD module, Functional Dyspepsia/FD module, Irritable&#xD;
             Bowel Syndrome/IBS module)&#xD;
&#xD;
          -  Subject with gastrointestinal disorders according to investigator's medical assessment&#xD;
&#xD;
          -  Subject taking drugs that might modify gastrointestinal function&#xD;
&#xD;
          -  Subject with severe disease as assessed by the investigator (ex: cancer, severe heart&#xD;
             disease, kidney disease, neurological disease or psychiatric disease, immunodeficiency&#xD;
             disorder)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris Le NEVE, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Danone Research, Palaiseau, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRS Clinical Research Services Mannheim GmbH</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy subjects</keyword>
  <keyword>Probiotics</keyword>
  <keyword>Breath test</keyword>
  <keyword>Dihydrogen</keyword>
  <keyword>Methane</keyword>
  <keyword>Intestinal gas production</keyword>
  <keyword>Gut microbiota</keyword>
  <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/NCT03015441
org study id: NU378
nct id: NCT03015441
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the effect of a 28-day fermented milk product
      consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in
      healthy subjects high H2 producers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Comparison between groups of the change from baseline (Day0) of breath H2 production elicited by a lactulose challenge test after 28 days of investigational product consumption
time frame: Baseline and after 28 days
measure: Comparison between groups of the change from baseline (Day0) of breath H2 production elicited by a lactulose challenge test after 14 days of investigational product consumption
time frame: Baseline and after 14 days
measure: Comparison between groups of the change from baseline (Day0) of breath CH4 production elicited by a lactulose challenge test after 14 days and 28 days of investigational product consumption
time frame: Baseline, after 14 days and after 28 days
measure: Comparison between groups of the change from baseline (Day0) in the fasting breath H2 and CH4 values after 14 days and 28 days of investigational product consumption
time frame: Baseline, after 14 days and after 28 days
measure: Comparison between groups of the change in composition and activity of gut microbiota from stool samples collected before and after 28 days of investigational product consumption
time frame: Baseline, after 28 days
measure: Adverse event
time frame: AE and SAE assessment through study completion and up to 14 days after the last study visit
arm group label: Arm 1: Fermented milk product containing probiotics
arm group type: Other
arm group label: Arm 2: Milk-based non-fermented dairy product
arm group type: Other
intervention type: Other
intervention name: Milk product fermented by lactic bacteria or not fermented
description: 2 pots of 125g consumed daily during 28 days
arm group label: Arm 1: Fermented milk product containing probiotics
arm group label: Arm 2: Milk-based non-fermented dairy product
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boris Le NEVE, PhD
role: Study Chair
affiliation: Danone Research, Palaiseau, France
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No