<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/NCT01702753</url>
  </required_header>
  <id_info>
    <org_study_id>PROBBIC I Study</org_study_id>
    <nct_id>NCT01702753</nct_id>
  </id_info>
  <brief_title>Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers</brief_title>
  <acronym>PROBBIC</acronym>
  <official_title>Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Zagreb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common&#xD;
      infections (gastrointestinal and respiratory) in healthy children who attend day care centre&#xD;
&#xD;
      This study is a prospective, randomized, double blind, placebo- controlled parallel study in&#xD;
      healthy children attending day care centers.&#xD;
&#xD;
      The study will investigate the effect of supplementation with the probiotic strain&#xD;
      Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and&#xD;
      respiratory infections and absence from day care due to infections.&#xD;
&#xD;
      The test product is a sachet containing 1 gram of powder. The test product will contain&#xD;
      minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is&#xD;
      an identical product except for the absence of probiotics.&#xD;
&#xD;
      The study includes 3 months (90 days) of intervention period. The study product will be&#xD;
      consumed daily in the evening together with a meal.&#xD;
&#xD;
      The consumption of the study products will be taken under the surveillance of the parents.&#xD;
&#xD;
      During the entire intervention period the subjects are not allowed to consume any probiotic&#xD;
      products other than the study products supplied to them by the study personnel.&#xD;
&#xD;
      Data on infections will be recorded in a diary, filled in and administered by the parents and&#xD;
      diary recorded by referring physician (on-call log).&#xD;
&#xD;
      All infections are to be diagnosed by the local physician. The incidence of infections will&#xD;
      be analyzed based on the information recorded in the diaries (parent's &amp; physician's).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Common infections</measure>
    <description>Number of children with gastrointestinal tract infections defined as diarrhoea (3 or more loose or watery stools in 24 hours or increase of number of stools for more than 50% in 24 hours) or vomiting (defined by physician and not a result of other symptoms including cough or diseases including gastroesophageal reflux disease or neurological conditions) or both.&#xD;
And number of children with respiratory tract infections defined as: pharyngitis, otitis, common cold, pneumonia, bronchitis and bronciolitis (all infections diagnosed by physician) Number of children with adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of symptoms</measure>
    <description>Duration of symptoms in days</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Infections with determined infective cause</measure>
    <description>Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Gastrointestinal Tract Infections</condition>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Bifidobacterium animalis subsp. lactis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bifidobacterium animalis subsp. lactis</intervention_name>
    <arm_group_label>Bifidobacterium animalis subsp. lactis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children attending day care at kindergartens located in the Zagreb's city&#xD;
             centre&#xD;
&#xD;
          -  Age from 1 year to 7 years&#xD;
&#xD;
          -  Attendance at daycare centers: &gt; 3 days per week&#xD;
&#xD;
          -  Signed informed consent by the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to&#xD;
             study start)&#xD;
&#xD;
          -  Neoplasms&#xD;
&#xD;
          -  Severe chronic disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>7 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Djecji vrtic Matija Gubec</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>July 24, 2013</last_update_submitted>
  <last_update_submitted_qc>July 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 26, 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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 26, 2015</submitted>
    <returned>November 25, 2015</returned>
    <submitted>November 26, 2015</submitted>
    <returned>January 4, 2016</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702753
org study id: PROBBIC I Study
nct id: NCT01702753
lead sponsor: 
has dmc: Yes
Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common
      infections (gastrointestinal and respiratory) in healthy children who attend day care centre

      This study is a prospective, randomized, double blind, placebo- controlled parallel study in
      healthy children attending day care centers.

      The study will investigate the effect of supplementation with the probiotic strain
      Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and
      respiratory infections and absence from day care due to infections.

      The test product is a sachet containing 1 gram of powder. The test product will contain
      minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is
      an identical product except for the absence of probiotics.

      The study includes 3 months (90 days) of intervention period. The study product will be
      consumed daily in the evening together with a meal.

      The consumption of the study products will be taken under the surveillance of the parents.

      During the entire intervention period the subjects are not allowed to consume any probiotic
      products other than the study products supplied to them by the study personnel.

      Data on infections will be recorded in a diary, filled in and administered by the parents and
      diary recorded by referring physician (on-call log).

      All infections are to be diagnosed by the local physician. The incidence of infections will
      be analyzed based on the information recorded in the diaries (parent's & physician's).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Common infections
description: Number of children with gastrointestinal tract infections defined as diarrhoea (3 or more loose or watery stools in 24 hours or increase of number of stools for more than 50% in 24 hours) or vomiting (defined by physician and not a result of other symptoms including cough or diseases including gastroesophageal reflux disease or neurological conditions) or both.
And number of children with respiratory tract infections defined as: pharyngitis, otitis, common cold, pneumonia, bronchitis and bronciolitis (all infections diagnosed by physician) Number of children with adverse events.
measure: Duration of symptoms
description: Duration of symptoms in days
measure: Infections with determined infective cause
description: Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)
arm group label: Bifidobacterium animalis subsp. lactis
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Bifidobacterium animalis subsp. lactis
arm group label: Bifidobacterium animalis subsp. lactis
criteria: 
gender: All
minimum age: 1 Year
maximum age: 7 Years
facility: 
country: Croatia
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
submitted: October 26, 2015
returned: November 25, 2015
submitted: November 26, 2015
returned: January 4, 2016