<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/NCT03814668</url>
  </required_header>
  <id_info>
    <org_study_id>NH-03978</org_study_id>
    <nct_id>NCT03814668</nct_id>
  </id_info>
  <brief_title>Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution</brief_title>
  <official_title>Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution: Randomized, Double-blind, Placebo-controlled, Positive-controlled, Three-way Crossover, Acute Lactose Challenge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danisco</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danisco</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>
      Study objectives:&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups&#xD;
      compared to placebo, measured by the incremental area under curve (iAUC) analysis&#xD;
&#xD;
      Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to&#xD;
      lactase group, measured by the incremental area under curve (iAUC) analysis&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
      Breath test&#xD;
&#xD;
        -  Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo&#xD;
&#xD;
        -  Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo&#xD;
&#xD;
      Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert&#xD;
      scale) in lactase and probiotic groups compared to placebo&#xD;
&#xD;
        -  Abdominal pain&#xD;
&#xD;
        -  Flatulence&#xD;
&#xD;
        -  Bloating&#xD;
&#xD;
        -  Nausea and vomiting&#xD;
&#xD;
        -  Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol&#xD;
           stool scale and number of bowel movements to be recorded)&#xD;
&#xD;
      Ancillary:&#xD;
&#xD;
        -  Baseline fasting BHC (ppm)&#xD;
&#xD;
        -  Breath methane CH4 (ppm)&#xD;
&#xD;
        -  Breath carbon dioxide CO2 (ppm)&#xD;
&#xD;
        -  Probiotic identification in feces before each lactose challenge by molecular methods&#xD;
&#xD;
        -  Gene test to determine lactase deficiency status at screening (following SNP variants to&#xD;
           be screened: 13910*C (Europe, Central Asia, commonly used) -22018*G (Europe), -13915*T&#xD;
           (Saudi-Arabia, Africa), -14010*G (Africa), -13907*C (Africa))&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath hydrogen concentration (BHC, ppm) in probiotic compared to placebo, measured by the iAUC analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control)</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of abdominal pain in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the severity of nausea in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the severity of nausea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Difference in baseline fasting BHC (ppm) between the treatments</measure>
    <time_frame>Baseline</time_frame>
    <description>Difference in baseline fasting BHC (ppm) between the treatments</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in breath methane concentration (ppm) between the treatments</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath methane concentration (ppm) between the treatments</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in breath carbon dioxide concentration (ppm) between the treatments</measure>
    <time_frame>During the 6-hour acute lactose challenge</time_frame>
    <description>Difference in breath methane concentration (ppm) between the treatments</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in the quantity of probiotic in fecal samples between the treatments</measure>
    <time_frame>48-hours before the visits</time_frame>
    <description>Difference in the quantity of probiotic in fecal samples between the treatments</description>
  </other_outcome>
  <other_outcome>
    <measure>Description of the SNP variants in each treatment group</measure>
    <time_frame>At screening</time_frame>
    <description>Description of the SNP variants in each treatment group</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Lactose Intolerance</condition>
  <arm_group>
    <arm_group_label>Probiotic powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One sachet of Probiotic powderwill be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lactase</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One sachet of Lactase powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One sachet of placebo powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Intake of probiotic</description>
    <arm_group_label>Probiotic powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactase</intervention_name>
    <description>Intake of lactase</description>
    <arm_group_label>Lactase</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intake of placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary, written, informed consent to participate in the study&#xD;
&#xD;
          2. Agreement to comply with the protocol and study restrictions&#xD;
&#xD;
          3. Healthy females and males of age 25 to 60 years (inclusive)&#xD;
&#xD;
          4. Self-declared, suspected or medically diagnosed lactose intolerance&#xD;
&#xD;
          5. Increase of more than 20 ppm in breath hydrogen within 3 h from the baseline fasting&#xD;
             breath hydrogen value&#xD;
&#xD;
          6. Participants who agree to maintain their usual dietary habits throughout the trial&#xD;
             period&#xD;
&#xD;
          7. Participants who agree not to consume probiotics, prebiotics, fermented milk, and/or&#xD;
             yogurt containing probiotics during the intervention period (Visits 3-5) and two weeks&#xD;
             before Visit 3 (2 weeks after screening visit)&#xD;
&#xD;
          8. Females of child-bearing potential who agree to use a medically approved method of&#xD;
             birth control&#xD;
&#xD;
          9. Ability of the participant (in the investigator's opinion) to comprehend the full&#xD;
             nature and purpose of the study including possible risks and side effects&#xD;
&#xD;
         10. Covered by Health Insurance System and / or in compliance with the recommendations of&#xD;
             National Law in force relating to biomedical research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal disorder or disease (e.g. Crohn's disease, ulcer, irritable bowel&#xD;
             syndrome (IBS), Celiac disease, small intestinal bacterial overgrowth (SIBO),&#xD;
             pancreatitis and disorders affecting gastrointestinal motility)&#xD;
&#xD;
          2. Diagnosed type 1 or type 2 diabetes&#xD;
&#xD;
          3. Prior abdominal surgery that, in the opinion of the investigator, may present a risk&#xD;
             for the participant or affect study results&#xD;
&#xD;
          4. Ongoing or recent (last 1 month) antibiotic treatment.&#xD;
&#xD;
          5. Use of laxatives or drugs known to affect gut motility 1 month preceding the screening&#xD;
             visit and during the study&#xD;
&#xD;
          6. Ongoing or recurrent use of proton pump inhibitors&#xD;
&#xD;
          7. Colonoscopy within 3 months before screening&#xD;
&#xD;
          8. History of recurrent colon cleansing and/or a colon cleansing within 3 months before&#xD;
             screening&#xD;
&#xD;
          9. Gastrointestinal infection within 1 month before screening or during the trial&#xD;
&#xD;
         10. Clinically significant underlying systemic illness that may preclude the participant's&#xD;
             ability to complete the trial or that may affect the study outcomes (e.g. bowel&#xD;
             cancer, prostate cancer, terminal illness)&#xD;
&#xD;
         11. History of diagnosed coronary heart disease/cardiovascular disease or artificial heart&#xD;
             valve&#xD;
&#xD;
         12. Any obstructive or restrictive respiratory syndrome/disease that may impact breath&#xD;
             test (e.g. asthma or chronic obstructive pulmonary disease (COPD))&#xD;
&#xD;
         13. Regular use of tobacco, snuff, nicotine and e-cigarette, and possible other inhaled&#xD;
             products. Light smokers (less than 5 cigarettes per day) who agree not to smoke during&#xD;
             the whole duration of the study may be included.&#xD;
&#xD;
         14. Self-declared history of alcohol abuse (for females: &gt;3 drinks on any single day and&#xD;
             &gt;7 drinks per week; for males: &gt;4 drinks on any single day and &gt;14 drinks per week)&#xD;
&#xD;
         15. Self-declared use of illicit drugs within 4 weeks preceding the screening visit&#xD;
&#xD;
         16. Pregnant or lactating female, or pregnancy planned during study period&#xD;
&#xD;
         17. Participants under administrative or legal supervision.&#xD;
&#xD;
         18. Participation in another study with any investigational product within 60 days of&#xD;
             screening&#xD;
&#xD;
         19. Clinically significant abnormal values in safety blood tests at screening&#xD;
&#xD;
         20. Other reasons that, in the opinion of the Investigator, make the participant&#xD;
             unsuitable for enrolment&#xD;
&#xD;
         21. Who would receive more than 4500€ as indemnities for his participation in biomedical&#xD;
             research within the last 12 months, including the indemnities for the present study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eurofins Optimed</name>
      <address>
        <city>Gières</city>
        <zip>38610</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>August 11, 2019</last_update_submitted>
  <last_update_submitted_qc>August 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</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>Lactose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03814668
org study id: NH-03978
nct id: NCT03814668
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study objectives:

      Primary:

      Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups
      compared to placebo, measured by the incremental area under curve (iAUC) analysis

      Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to
      lactase group, measured by the incremental area under curve (iAUC) analysis

      Secondary:

      Breath test

        -  Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo

        -  Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo

      Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert
      scale) in lactase and probiotic groups compared to placebo

        -  Abdominal pain

        -  Flatulence

        -  Bloating

        -  Nausea and vomiting

        -  Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol
           stool scale and number of bowel movements to be recorded)

      Ancillary:

        -  Baseline fasting BHC (ppm)

        -  Breath methane CH4 (ppm)

        -  Breath carbon dioxide CO2 (ppm)

        -  Probiotic identification in feces before each lactose challenge by molecular methods

        -  Gene test to determine lactase deficiency status at screening (following SNP variants to
           be screened: 13910*C (Europe, Central Asia, commonly used) -22018*G (Europe), -13915*T
           (Saudi-Arabia, Africa), -14010*G (Africa), -13907*C (Africa))
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo
time frame: During the 6-hour acute lactose challenge
description: Difference in breath hydrogen concentration (BHC, ppm) in probiotic compared to placebo, measured by the iAUC analysis
measure: Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo
time frame: During the 6-hour acute lactose challenge
description: Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis
measure: Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control)
time frame: During the 6-hour acute lactose challenge
description: Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis
measure: Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
time frame: During the 6-hour acute lactose challenge
description: Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
measure: Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
time frame: During the 6-hour acute lactose challenge
description: Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
measure: Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
time frame: During the 6-hour acute lactose challenge
description: Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
measure: Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
time frame: During the 6-hour acute lactose challenge
description: Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
measure: Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of abdominal pain in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the severity of nausea in probioticgroup compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the severity of nausea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
time frame: During the 6-hour acute lactose challenge
description: Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
measure: Difference in baseline fasting BHC (ppm) between the treatments
time frame: Baseline
description: Difference in baseline fasting BHC (ppm) between the treatments
measure: Difference in breath methane concentration (ppm) between the treatments
time frame: During the 6-hour acute lactose challenge
description: Difference in breath methane concentration (ppm) between the treatments
measure: Difference in breath carbon dioxide concentration (ppm) between the treatments
time frame: During the 6-hour acute lactose challenge
description: Difference in breath methane concentration (ppm) between the treatments
measure: Difference in the quantity of probiotic in fecal samples between the treatments
time frame: 48-hours before the visits
description: Difference in the quantity of probiotic in fecal samples between the treatments
measure: Description of the SNP variants in each treatment group
time frame: At screening
description: Description of the SNP variants in each treatment group
arm group label: Probiotic powder
arm group type: Experimental
description: One sachet of Probiotic powderwill be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.
arm group label: Lactase
arm group type: Active Comparator
description: One sachet of Lactase powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.
arm group label: Placebo
arm group type: Placebo Comparator
description: One sachet of placebo powder will be consumed with 25 g lactose in 250 ml of water in the beginning of a 6-hour challenge at the study visits.
intervention type: Dietary Supplement
intervention name: Probiotic
description: Intake of probiotic
arm group label: Probiotic powder
intervention type: Dietary Supplement
intervention name: Lactase
description: Intake of lactase
arm group label: Lactase
intervention type: Other
intervention name: Placebo
description: Intake of placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Lactose Intolerance
sharing ipd: Undecided
submitted: January 10, 2023