<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/NCT01702766</url>
  </required_header>
  <id_info>
    <org_study_id>PROBBIC II Study</org_study_id>
    <nct_id>NCT01702766</nct_id>
  </id_info>
  <brief_title>Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children</brief_title>
  <acronym>PROBIC II</acronym>
  <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;
      nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be&#xD;
      defined as infections which develop more than 48 hours after admission and they are not&#xD;
      present or incubating on admission&#xD;
&#xD;
      This study is a prospective, randomized, double blind, placebo- controlled parallel study in&#xD;
      children hospitalized at Children's hospital Zagreb.&#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.&#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) probiotic per serving.&#xD;
&#xD;
      The placebo product is an identical product except for the absence of probiotics.&#xD;
&#xD;
      The study includes an intervention period lasting the length of the hospital stay.&#xD;
&#xD;
      The study product will be consumed daily in the morning together with breakfast.&#xD;
&#xD;
      The consumption of the study products will be taken under the surveillance of the physician.&#xD;
&#xD;
      Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of&#xD;
      infections will be analyzed based on the information recorded in the CRF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_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>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Common infections in children</measure>
    <description>Number of children with common infections (gastrointestinal and respiratory infections):&#xD;
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;
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>Severity of infection</measure>
    <description>Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <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;
          -  Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb&#xD;
&#xD;
          -  Age from 1 year to 18 years&#xD;
&#xD;
          -  Signed informed consent by the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Infants from neonatal period until 1 year of age&#xD;
&#xD;
          -  Re-hospitalisation (readmission in a hospital within one month)&#xD;
&#xD;
          -  Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to&#xD;
             hospitalization)&#xD;
&#xD;
          -  Neoplasms&#xD;
&#xD;
          -  Severe chronic diseases&#xD;
&#xD;
          -  Hospitalization shorter than 3 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital Zagreb</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>May 25, 2015</submitted>
    <returned>June 10, 2015</returned>
    <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/NCT01702766
org study id: PROBBIC II Study
nct id: NCT01702766
lead sponsor: 
has dmc: Yes
Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common
      nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be
      defined as infections which develop more than 48 hours after admission and they are not
      present or incubating on admission

      This study is a prospective, randomized, double blind, placebo- controlled parallel study in
      children hospitalized at Children's hospital Zagreb.

      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.

      The test product is a sachet containing 1 gram of powder. The test product will contain
      minimum 1 billion CFU (colony forming units) probiotic per serving.

      The placebo product is an identical product except for the absence of probiotics.

      The study includes an intervention period lasting the length of the hospital stay.

      The study product will be consumed daily in the morning together with breakfast.

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

      Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of
      infections will be analyzed based on the information recorded in the CRF.
intervention model: Parallel Assignment
primary purpose: Prevention
measure: Common infections in children
description: Number of children with common infections (gastrointestinal and respiratory infections):
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.
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: Severity of infection
description: Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale
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: 18 Years
facility: 
country: Croatia
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
submitted: May 25, 2015
returned: June 10, 2015
submitted: October 26, 2015
returned: November 25, 2015
submitted: November 26, 2015
returned: January 4, 2016