<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/NCT01731392</url>
  </required_header>
  <id_info>
    <org_study_id>10.50.NRC</org_study_id>
    <nct_id>NCT01731392</nct_id>
  </id_info>
  <brief_title>Children Immune Functions(2)</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effect of milk-based formulas on infections and immune functions in&#xD;
      healthy children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Particular attention was paid to the role played by nutrition in supporting the gut&#xD;
      ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial&#xD;
      effects of probiotics were demonstrated for different infectious diseases, GII and URI.&#xD;
&#xD;
      The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly&#xD;
      documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Days with diarrhea</measure>
    <time_frame>during the 5 months of follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of episodes of Upper Respiratory Infections</measure>
    <time_frame>5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of episodes of Upper Respiratory Infections</measure>
    <time_frame>5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of episodes of Upper Respiratory Infections</measure>
    <time_frame>5 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">604</enrollment>
  <condition>Diarrhea</condition>
  <condition>Upper Respiratory Infections</condition>
  <arm_group>
    <arm_group_label>Milk with Bifidobacteria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>duration of the treatment is 5 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Milk with non replicating lactobacilli</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>duration of the treatment is 5 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Semi skimmed milk</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>duration of the treatment is 5 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk with Bifidobacteria</intervention_name>
    <description>A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.</description>
    <arm_group_label>Milk with Bifidobacteria</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk with non replicating lactobacilli</intervention_name>
    <description>A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.</description>
    <arm_group_label>Milk with non replicating lactobacilli</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.</description>
    <arm_group_label>Semi skimmed milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents written and signed informed consent for participation in the study.&#xD;
&#xD;
          -  Healthy children aged 1 to 3 years that are no more breastfed.&#xD;
&#xD;
          -  Go to a selected nursery and / or pediatrician.&#xD;
&#xD;
          -  Parents must have a phone at home or a cellular phone to call the paediatrician.&#xD;
&#xD;
          -  No consumption of commercial products containing probiotics or prebiotics during the 3&#xD;
             weeks before and during the study period.&#xD;
&#xD;
          -  Parents are able to give their children, twice daily, 2 milk servings on a 5 months&#xD;
             period.&#xD;
&#xD;
          -  Children not being intensive consumers of regular yoghurts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rotavirus and flu vaccines administration within the last 3 months prior to V1&#xD;
             (baseline visit).&#xD;
&#xD;
          -  Used antibiotics within the last 30 days prior to V1 (baseline visit).&#xD;
&#xD;
          -  Congenital or chronic disease.&#xD;
&#xD;
          -  Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.&#xD;
&#xD;
          -  Significant illness within the two weeks prior to start of the study or any active&#xD;
             systemic infection or medical condition that may require treatment or therapeutic&#xD;
             intervention during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saptawati Bardosono, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nutrition Department, Faculty of Medicine,</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. Nutrition, Faculty of Medicine University of Indonesia</name>
      <address>
        <city>Jakarta</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>December 11, 2013</last_update_submitted>
  <last_update_submitted_qc>December 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diarrhea</keyword>
  <keyword>Children</keyword>
  <keyword>Lactobacilli</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <!-- 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/NCT01731392
org study id: 10.50.NRC
nct id: NCT01731392
lead sponsor: 
has dmc: No
To investigate the effect of milk-based formulas on infections and immune functions in
      healthy children.
Particular attention was paid to the role played by nutrition in supporting the gut
      ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial
      effects of probiotics were demonstrated for different infectious diseases, GII and URI.

      The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly
      documented.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Days with diarrhea
time frame: during the 5 months of follow up
measure: Number of episodes of Upper Respiratory Infections
time frame: 5 months
measure: Duration of episodes of Upper Respiratory Infections
time frame: 5 months
measure: Severity of episodes of Upper Respiratory Infections
time frame: 5 months
arm group label: Milk with Bifidobacteria
arm group type: Experimental
description: duration of the treatment is 5 months
arm group label: Milk with non replicating lactobacilli
arm group type: Active Comparator
description: duration of the treatment is 5 months
arm group label: Semi skimmed milk
arm group type: Placebo Comparator
description: duration of the treatment is 5 months
intervention type: Dietary Supplement
intervention name: Milk with Bifidobacteria
description: A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
arm group label: Milk with Bifidobacteria
intervention type: Dietary Supplement
intervention name: Milk with non replicating lactobacilli
description: A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
arm group label: Milk with non replicating lactobacilli
intervention type: Dietary Supplement
intervention name: placebo
description: A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
arm group label: Semi skimmed milk
criteria: 
gender: All
minimum age: 1 Year
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Saptawati Bardosono, MSc
role: Principal Investigator
affiliation: Nutrition Department, Faculty of Medicine,
facility: 
country: Indonesia
responsible party type: Sponsor
mesh term: Infections
mesh term: Respiratory Tract Infections
mesh term: Diarrhea