<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/NCT01660698</url>
  </required_header>
  <id_info>
    <org_study_id>11.03.MET</org_study_id>
    <nct_id>NCT01660698</nct_id>
  </id_info>
  <brief_title>Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals</brief_title>
  <official_title>Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the current study is to evaluate the effect of administering a probiotic&#xD;
      strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in&#xD;
      seasonal allergic rhinitis subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To identify immune markers in allergic individuals that are impacted by probiotic treatment&#xD;
      during seasonal exposure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)</measure>
    <time_frame>0 (baseline), 1 and 2 months</time_frame>
    <description>A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)</measure>
    <time_frame>0 (baseline), 1, and 2 months</time_frame>
    <description>A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)</measure>
    <time_frame>Measures at baseline, 1, and 2 months</time_frame>
    <description>TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Seasonal Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>maltodextrin powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>probiotic blended in maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>maltodextrin powder</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>probiotic blended in maltodextrin powder</description>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed allergy (allergic rhinitis) to grass pollen &gt; 1 year and positive SPT &gt; 3mm&#xD;
             wheal diameter to grass pollen.&#xD;
&#xD;
          -  Age 20-65 years adults&#xD;
&#xD;
          -  Body Mass Index 19- 29 (people in the normal and overweight range)&#xD;
&#xD;
          -  Having obtained his/her informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  Family history of congenital immunodeficiency&#xD;
&#xD;
          -  Regular consumption of immunosuppressive or anti-inflammatory treatment&#xD;
&#xD;
          -  Under medication against allergy (e.g. anti histaminic)&#xD;
&#xD;
          -  Avoid regular consumption of probiotic and other dietary nutritional interventions&#xD;
&#xD;
          -  Have a high alcohol consumption (more than 1 drink/day)&#xD;
&#xD;
          -  Consumption of illicit drugs&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
               -  Subject who cannot be expected to comply with the study procedures, including&#xD;
                  consuming the test products&#xD;
&#xD;
               -  Currently participating or having participated in another clinical trial during&#xD;
                  the last 4 weeks prior to the beginning of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Maurice Beaumont, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Société des Produits Nestlé (SPN)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Metabolic Unit, Nestlé Research Center</name>
      <address>
        <city>Lausanne</city>
        <state>VD</state>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Singh A, Hacini-Rachinel F, Gosoniu ML, Bourdeau T, Holvoet S, Doucet-Ladeveze R, Beaumont M, Mercenier A, Nutten S. Immune-modulatory effect of probiotic Bifidobacterium lactis NCC2818 in individuals suffering from seasonal allergic rhinitis to grass pollen: an exploratory, randomized, placebo-controlled clinical trial. Eur J Clin Nutr. 2013 Feb;67(2):161-7. doi: 10.1038/ejcn.2012.197. Epub 2013 Jan 9.</citation>
    <PMID>23299716</PMID>
  </results_reference>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>April 2, 2013</results_first_submitted>
  <results_first_submitted_qc>July 11, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 12, 2013</results_first_posted>
  <last_update_submitted>July 11, 2013</last_update_submitted>
  <last_update_submitted_qc>July 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 12, 2013</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>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment at the Metabolic Unit, (study no. 11.03.MET, NCT01660698) during the Grass Pollen (GP) season. Twenty seven adults volunteered, of which twenty four who gave written informed consent were screened for clinical history of allergy to GP &gt; 2 years and a confirmatory skin prick test (SPT) to GP. Twenty subjects were randomized.</recruitment_details>
      <pre_assignment_details>Subjects assigned to either: probiotic or placebo groups and taking assigned product for 8 weeks with three visits: V1(at baseline), V2 (4 weeks after treatment) and V3 (8 weeks after treatment).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>maltodextrin powder&#xD;
Maltodextrin : maltodextrin powder</description>
        </group>
        <group group_id="P2">
          <title>Probiotic</title>
          <description>probiotic blended in maltodextrin&#xD;
Probiotic : probiotic blended in maltodextrin powder</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>maltodextrin powder&#xD;
Maltodextrin : maltodextrin powder</description>
        </group>
        <group group_id="B2">
          <title>Probiotic</title>
          <description>probiotic blended in maltodextrin&#xD;
Probiotic : probiotic blended in maltodextrin powder</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34" lower_limit="29.25" upper_limit="44"/>
                    <measurement group_id="B2" value="35.5" lower_limit="31.5" upper_limit="38"/>
                    <measurement group_id="B3" value="34.7" lower_limit="29.25" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Switzerland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)</title>
        <description>A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.</description>
        <time_frame>0 (baseline), 1 and 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>maltodextrin powder&#xD;
Maltodextrin : maltodextrin powder</description>
          </group>
          <group group_id="O2">
            <title>Probiotic</title>
            <description>probiotic blended in maltodextrin&#xD;
Probiotic : probiotic blended in maltodextrin powder</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)</title>
          <description>A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL13 at V1 (beginning of product intake)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1238" spread="1453"/>
                    <measurement group_id="O2" value="720" spread="854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL13 at 1 month (4 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="975" spread="1019"/>
                    <measurement group_id="O2" value="998" spread="1383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL13 at 2 months (8 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="968" spread="1206"/>
                    <measurement group_id="O2" value="218" spread="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)</title>
        <description>TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.</description>
        <time_frame>Measures at baseline, 1, and 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>maltodextrin powder&#xD;
Maltodextrin : maltodextrin powder</description>
          </group>
          <group group_id="O2">
            <title>Probiotic</title>
            <description>probiotic blended in maltodextrin&#xD;
Probiotic : probiotic blended in maltodextrin powder</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)</title>
          <description>TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TNSS score at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="3.11"/>
                    <measurement group_id="O2" value="4.90" spread="3.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNSS score at 1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread="1.86"/>
                    <measurement group_id="O2" value="3.92" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNSS score at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="2.04"/>
                    <measurement group_id="O2" value="1.50" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells</title>
        <time_frame>8 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups</title>
        <time_frame>8 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells</title>
        <time_frame>8 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)</title>
        <description>A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.</description>
        <time_frame>0 (baseline), 1, and 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>maltodextrin powder&#xD;
Maltodextrin : maltodextrin powder</description>
          </group>
          <group group_id="O2">
            <title>Probiotic</title>
            <description>probiotic blended in maltodextrin&#xD;
Probiotic : probiotic blended in maltodextrin powder</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)</title>
          <description>A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-5 at baseline (begining of product intake)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1439" spread="1501"/>
                    <measurement group_id="O2" value="700" spread="683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-5 at 1 month (4 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1191" spread="1005"/>
                    <measurement group_id="O2" value="980" spread="905"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-5 at 2 months (8 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1277" spread="956"/>
                    <measurement group_id="O2" value="323" spread="301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline until 4 weeks following the last product intake</time_frame>
      <desc>All adverse events were documented on the the e-CRFs. In the case of a SAE persisting beyond trial termination, a follow up visit may be required. Any potential cause-effect relationship between the study product and the adverse event was assessed based on all examinations and laboratory analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>maltodextrin powder&#xD;
Maltodextrin : maltodextrin powder</description>
        </group>
        <group group_id="E2">
          <title>Probiotic</title>
          <description>probiotic blended in maltodextrin&#xD;
Probiotic : probiotic blended in maltodextrin powder</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Maurice Beaumont, Principal Investigator</name_or_title>
      <organization>Clinical Development Unit / Metabolic Unit</organization>
      <phone>+41217858054</phone>
      <email>maurice.beaumont@rdls.nestle.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01660698
org study id: 11.03.MET
nct id: NCT01660698
lead sponsor: 
has dmc: Yes
The purpose of the current study is to evaluate the effect of administering a probiotic
      strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in
      seasonal allergic rhinitis subjects.
To identify immune markers in allergic individuals that are impacted by probiotic treatment
      during seasonal exposure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)
time frame: 0 (baseline), 1 and 2 months
description: A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.
measure: Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)
time frame: 0 (baseline), 1, and 2 months
description: A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.
measure: Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)
time frame: Measures at baseline, 1, and 2 months
description: TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.
measure: Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
time frame: 8 weeks
measure: Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
time frame: 8 weeks
measure: Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
time frame: 8 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: maltodextrin powder
arm group label: Probiotic
arm group type: Active Comparator
description: probiotic blended in maltodextrin
intervention type: Dietary Supplement
intervention name: Maltodextrin
description: maltodextrin powder
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Probiotic
description: probiotic blended in maltodextrin powder
arm group label: Probiotic
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dr Maurice Beaumont, MD, PhD
role: Principal Investigator
affiliation: Société des Produits Nestlé (SPN)
facility: 
country: Switzerland
citation: Singh A, Hacini-Rachinel F, Gosoniu ML, Bourdeau T, Holvoet S, Doucet-Ladeveze R, Beaumont M, Mercenier A, Nutten S. Immune-modulatory effect of probiotic Bifidobacterium lactis NCC2818 in individuals suffering from seasonal allergic rhinitis to grass pollen: an exploratory, randomized, placebo-controlled clinical trial. Eur J Clin Nutr. 2013 Feb;67(2):161-7. doi: 10.1038/ejcn.2012.197. Epub 2013 Jan 9.
PMID: 23299716
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 