<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/NCT01717534</url>
  </required_header>
  <id_info>
    <org_study_id>10.42.NRC</org_study_id>
    <nct_id>NCT01717534</nct_id>
  </id_info>
  <brief_title>Children Immune Functions</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status 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>
      The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on&#xD;
      diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind,&#xD;
      placebo-controlled study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was&#xD;
      clearly documented and the purpose of this planned study is to investigate the effect on&#xD;
      reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old.&#xD;
      Moreover, the study is intended to evaluate the impact on the immune status of the children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 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 5 months of study period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of episodes of upper respiratory infections</measure>
    <time_frame>during 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of upper respiratory infections</measure>
    <time_frame>during 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of upper respiratory infections</measure>
    <time_frame>during 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of gastrointestinal infections</measure>
    <time_frame>during 5 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">374</enrollment>
  <condition>Diarrhea</condition>
  <condition>Upper Respiratory Infections</condition>
  <arm_group>
    <arm_group_label>Heat-treated lactobacilli</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.&#xD;
The duration of the treatment is 5 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.&#xD;
The duration of the treatment is 5 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>heat-treated lactobacilli or placebo</intervention_name>
    <description>Daily supplement of sachet with 1 g of powder over a 5 months period.</description>
    <arm_group_label>Heat-treated lactobacilli</arm_group_label>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parents written and signed informed consent for participation in the study: parents&#xD;
             agree with the participation in the study, dated and signed informed consent form&#xD;
             prior to any study related procedure.&#xD;
&#xD;
          2. Healthy children aged 1 to 4 years&#xD;
&#xD;
          3. No more breastfed.&#xD;
&#xD;
          4. Daily home cared and going to a selected pediatrician.&#xD;
&#xD;
          5. Parents must have a phone at home or a cellular phone to call the paediatrician.&#xD;
&#xD;
          6. No consumption of commercial products containing probiotics and / or prebiotics during&#xD;
             the 3 weeks before and during the study period.&#xD;
&#xD;
          7. Children not being intensive consumers of regular yoghurts&#xD;
&#xD;
          8. Parents are able to keep a daily record of symptoms and to administrate the study&#xD;
             products.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vaccine administration within the last 3 months prior study start.&#xD;
&#xD;
          2. Used antibiotics within the last month&#xD;
&#xD;
          3. Congenital or chronic disease.&#xD;
&#xD;
          4. Any kind of immunodeficiency or allergy.&#xD;
&#xD;
          5. Acute infection or fever.&#xD;
&#xD;
          6. Significant illness within the two weeks prior to the start of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>48 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angeles Nava Hernández, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center of Clinical Research of Querétaro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos A. Mena Cedillos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Tlalnepantla</city>
        <state>Edo. De Méx</state>
        <zip>54055</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Clinicos de Queretaro S.c.</name>
      <address>
        <city>Querétaro</city>
        <state>Qro</state>
        <zip>76000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>August 26, 2013</last_update_submitted>
  <last_update_submitted_qc>August 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diarrhea</keyword>
  <keyword>Children</keyword>
  <keyword>Heat-treated 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/NCT01717534
org study id: 10.42.NRC
nct id: NCT01717534
lead sponsor: 
has dmc: No
The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on
      diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind,
      placebo-controlled study.
The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was
      clearly documented and the purpose of this planned study is to investigate the effect on
      reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old.
      Moreover, the study is intended to evaluate the impact on the immune status of the children.
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 5 months of study period
measure: Number of episodes of upper respiratory infections
time frame: during 5 months
measure: Duration of upper respiratory infections
time frame: during 5 months
measure: Severity of upper respiratory infections
time frame: during 5 months
measure: Severity of gastrointestinal infections
time frame: during 5 months
arm group label: Heat-treated lactobacilli
arm group type: Experimental
description: One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.
The duration of the treatment is 5 months.
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.
The duration of the treatment is 5 months.
intervention type: Dietary Supplement
intervention name: heat-treated lactobacilli or placebo
description: Daily supplement of sachet with 1 g of powder over a 5 months period.
arm group label: Heat-treated lactobacilli
arm group label: Maltodextrin
criteria: 
gender: All
minimum age: 12 Months
maximum age: 48 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Angeles Nava Hernández, MD
role: Principal Investigator
affiliation: Center of Clinical Research of Querétaro
last name: Carlos A. Mena Cedillos, MD
role: Principal Investigator
affiliation: Clinical Research Institute
facility: 
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Infections
mesh term: Respiratory Tract Infections
mesh term: Diarrhea