<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/NCT01669603</url>
  </required_header>
  <id_info>
    <org_study_id>16241</org_study_id>
    <nct_id>NCT01669603</nct_id>
  </id_info>
  <brief_title>Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)</brief_title>
  <acronym>EPIARR</acronym>
  <official_title>Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DuPont Nutrition and Health</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive&#xD;
      host responses to rhinovirus infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The common cold is a ubiquitous illness of man that is associated with significant medical&#xD;
      and socioeconomic consequences. Current treatments for the common cold that have proven&#xD;
      efficacy are limited to pharmacologic agents that are directed at specific symptoms. These&#xD;
      treatments- antihistamines, nasal decongestants and analgesics- have limited effectiveness,&#xD;
      generally relieving the target symptom by 15-25% at the peak of activity, and are associated&#xD;
      with bothersome side effects. There are no currently effective treatments for prevention of&#xD;
      rhinovirus infections.&#xD;
&#xD;
      Probiotics have been defined by FAO/WHO as &quot;Live microorganisms which when administered in&#xD;
      adequate amount confer a health benefit on a host.&quot; The most common probiotics belong to&#xD;
      Lactobacillus or Bifidobacterium genera. Bifidobacteria are natural human gut inhabitants&#xD;
      that were discovered over a hundred years ago from the feces of breast-fed infants. The study&#xD;
      product Bifidobacterium animalis subspecies (subsp.) lactis Bl-04 (Bl-04) has been&#xD;
      genetically characterized as B. animalis subsp. lactis by 16S rRNA gene sequencing and full&#xD;
      genome sequence comparison. Bl-04 has been deposited in the American Type Culture Collections&#xD;
      safe deposit as SD5219.&#xD;
&#xD;
      This study will test the hypothesis that ingestion of a probiotic Bifidobacterium animalis&#xD;
      subsp. lactis Bl-04 will alter the innate and adaptive host response to rhinovirus infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin-8 (IL-8)</measure>
    <time_frame>72 hours</time_frame>
    <description>Nasal lavage will be performed to collect and measure IL-8.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">789</enrollment>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>Bifidobacterium animalis lactis Bl-04</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bifidobacterium lactis Bl-04</intervention_name>
    <description>The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.</description>
    <arm_group_label>Bifidobacterium animalis lactis Bl-04</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rhinovirus</intervention_name>
    <description>rhinovirus for experimental challenge</description>
    <arm_group_label>Bifidobacterium animalis lactis Bl-04</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        AT ENROLLMENT:&#xD;
&#xD;
          -  Subject must be 18-60 years of age.&#xD;
&#xD;
          -  Subject must read and sign a copy of the approved Consent Form&#xD;
&#xD;
          -  Female subjects must be using an effective birth control method.&#xD;
&#xD;
        INCLUSION CRITERIA AT DAY -28&#xD;
&#xD;
          -  Subject must read and sign a copy of the approved Consent Form&#xD;
&#xD;
        AT CHALLENGE:&#xD;
&#xD;
          -  Female subjects must be using an effective birth control method.&#xD;
&#xD;
          -  Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to&#xD;
             rhinovirus type 39&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        AT ENROLLMENT:&#xD;
&#xD;
          -  Current cancer diagnosis or immunosuppressive therapy in the last 6 months&#xD;
&#xD;
          -  Any clinically significant abnormalities of the upper respiratory tract&#xD;
&#xD;
          -  Any clinically significant acute or chronic respiratory illness&#xD;
&#xD;
          -  Any clinically significant bleeding tendency by history&#xD;
&#xD;
          -  Hypertension that requires treatment with antihypertensive medications&#xD;
&#xD;
          -  History of angina or other clinically significant cardiac disease&#xD;
&#xD;
          -  Any medical condition that in the opinion of the Principal Investigator is cause for&#xD;
             exclusion from the study&#xD;
&#xD;
          -  History of regular use (more than 3 days in 7) of tobacco products within the&#xD;
             preceding two weeks&#xD;
&#xD;
          -  History of drug or alcohol abuse in the 6 months preceding the study&#xD;
&#xD;
        EXCLUSION CRITERIA AT DAY -28&#xD;
&#xD;
          -  Antibiotic use within 3 months prior to study start&#xD;
&#xD;
          -  Female subjects with a positive urine pregnancy screen.&#xD;
&#xD;
          -  History of use of probiotics in the preceding 2 weeks.&#xD;
&#xD;
        EXCLUSION CRITERIA AT CHALLENGE:&#xD;
&#xD;
          -  Any upper respiratory infection or allergic rhinitis in the two weeks prior to the&#xD;
             start of the study&#xD;
&#xD;
          -  Any medical condition that in the opinion of the Principal Investigator is cause for&#xD;
             exclusion from the study&#xD;
&#xD;
          -  Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the two&#xD;
             weeks prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald Turner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>March 8, 2017</results_first_submitted>
  <results_first_submitted_qc>April 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 25, 2017</results_first_posted>
  <last_update_submitted>April 20, 2017</last_update_submitted>
  <last_update_submitted_qc>April 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Ronald Turner, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Common cold</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Common Cold</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>789 subjects were screened for participation. 190 subjects met all study criteria for randomization to study intervention.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bifidobacterium Animalis Lactis Bl-04</title>
          <description>Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.&#xD;
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.&#xD;
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Volunteers challenged with rhinovirus who met protocol definitions for analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Bifidobacterium Animalis Lactis Bl-04</title>
          <description>Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.&#xD;
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.&#xD;
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.</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="95"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="190"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="57"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="58"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="115"/>
                  </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>
          <population>analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="57"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22" spread="6"/>
                    <measurement group_id="B2" value="23" spread="7"/>
                    <measurement group_id="B3" value="23" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="57"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="57"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="58"/>
                    <count group_id="B2" value="57"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="95"/>
                    <count group_id="B2" value="95"/>
                    <count group_id="B3" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Interleukin-8 (IL-8)</title>
        <description>Nasal lavage will be performed to collect and measure IL-8.</description>
        <time_frame>72 hours</time_frame>
        <population>analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study</population>
        <group_list>
          <group group_id="O1">
            <title>Bifidobacterium Animalis Lactis Bl-04</title>
            <description>Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.&#xD;
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.&#xD;
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.</description>
          </group>
        </group_list>
        <measure>
          <title>Interleukin-8 (IL-8)</title>
          <description>Nasal lavage will be performed to collect and measure IL-8.</description>
          <population>analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study</population>
          <units>pg/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133" spread="2.5"/>
                    <measurement group_id="O2" value="122" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bifidobacterium Animalis Lactis Bl-04</title>
          <description>Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.&#xD;
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.&#xD;
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.</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="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>gastrointestinal</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>respiratory</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Ronald Turner</name_or_title>
      <organization>University of Virginia</organization>
      <email>rbt2n@virginia.edu</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/NCT01669603
org study id: 16241
nct id: NCT01669603
lead sponsor: 
collaborator: 
has dmc: No
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive
      host responses to rhinovirus infection.
The common cold is a ubiquitous illness of man that is associated with significant medical
      and socioeconomic consequences. Current treatments for the common cold that have proven
      efficacy are limited to pharmacologic agents that are directed at specific symptoms. These
      treatments- antihistamines, nasal decongestants and analgesics- have limited effectiveness,
      generally relieving the target symptom by 15-25% at the peak of activity, and are associated
      with bothersome side effects. There are no currently effective treatments for prevention of
      rhinovirus infections.

      Probiotics have been defined by FAO/WHO as "Live microorganisms which when administered in
      adequate amount confer a health benefit on a host." The most common probiotics belong to
      Lactobacillus or Bifidobacterium genera. Bifidobacteria are natural human gut inhabitants
      that were discovered over a hundred years ago from the feces of breast-fed infants. The study
      product Bifidobacterium animalis subspecies (subsp.) lactis Bl-04 (Bl-04) has been
      genetically characterized as B. animalis subsp. lactis by 16S rRNA gene sequencing and full
      genome sequence comparison. Bl-04 has been deposited in the American Type Culture Collections
      safe deposit as SD5219.

      This study will test the hypothesis that ingestion of a probiotic Bifidobacterium animalis
      subsp. lactis Bl-04 will alter the innate and adaptive host response to rhinovirus infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Interleukin-8 (IL-8)
time frame: 72 hours
description: Nasal lavage will be performed to collect and measure IL-8.
arm group label: Bifidobacterium animalis lactis Bl-04
arm group type: Experimental
description: Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
intervention type: Dietary Supplement
intervention name: Bifidobacterium lactis Bl-04
description: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.
arm group label: Bifidobacterium animalis lactis Bl-04
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
arm group label: Placebo
intervention type: Biological
intervention name: Rhinovirus
description: rhinovirus for experimental challenge
arm group label: Bifidobacterium animalis lactis Bl-04
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald Turner, MD
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Ronald Turner, MD
investigator title: Principal Investigator
mesh term: Common Cold
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 