<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/NCT01681355</url>
  </required_header>
  <id_info>
    <org_study_id>BLU.1.C/A</org_study_id>
    <nct_id>NCT01681355</nct_id>
  </id_info>
  <brief_title>Gastrointestinal Tolerance Study of a New Infant Formula</brief_title>
  <acronym>BOOGIE</acronym>
  <official_title>Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danone Asia Pacific Holdings Pte, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danone Asia Pacific Holdings Pte, Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is initiated to investigate the gastrointestinal tolerance of a new infant formula&#xD;
      in healthy, term, Asian infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastrointestinal tolerance</measure>
    <time_frame>up to Week 6</time_frame>
    <description>Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Anthropometry</measure>
    <time_frame>Week 3, Week 6</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Use of medication and nutritional supplements</measure>
    <time_frame>Week 1, Week 3, Week 6 and Week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number, type and severity of (serious) adverse events</measure>
    <time_frame>Week 1, Week 3, Week 6 and Week 8</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy Infants</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infant Formula</intervention_name>
    <description>Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, well-nourished, term, Asian infants (gestational age ≥ 37 1/7 and ≤ 41 6/7&#xD;
             weeks)&#xD;
&#xD;
          -  The mother had unequivocally decided not to exclusively breast-feed&#xD;
&#xD;
          -  Formula fed for at least one week, receiving at least two formula feedings per day&#xD;
&#xD;
          -  Birth weight appropriate for gestational age (AGA), 2500-4000g&#xD;
&#xD;
          -  Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 17 weeks&#xD;
&#xD;
          -  Infants known to have current or previous illnesses/conditions or intervention which&#xD;
             could interfere with the study (impacting tolerance and/or growth), such as&#xD;
             gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome,&#xD;
             malnutrition, congenital immunodeficiency, or major surgery, as per investigator's&#xD;
             clinical judgement&#xD;
&#xD;
          -  Infants who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding&#xD;
             study start.&#xD;
&#xD;
          -  Infants who used any medication or nutritional supplements (except for vitamin&#xD;
             supplementation to complement breastfeeding) in the 4 weeks preceding study start.&#xD;
&#xD;
          -  Infants who have medical conditions for which a special diet other than standard (non&#xD;
             hydrolysed) cow's milk-based infant formula is required (such as cow's milk allergy,&#xD;
             soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance,&#xD;
             galactosemia).&#xD;
&#xD;
          -  Infants with any history of or current participation in any other study involving&#xD;
             investigational or marketed products.&#xD;
&#xD;
          -  Investigator's uncertainty about the willingness or ability of the parents to comply&#xD;
             with the protocol requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan van der Mooren, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Danone Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Panembahan Senopati Distric Hospital</name>
      <address>
        <city>Bantul</city>
        <state>DIY Yogyakarta</state>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sakina Idaman Mothers and Children Hospital</name>
      <address>
        <city>Yogyakarta</city>
        <state>DIY Yogyakarta</state>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Songkhla University Hospital</name>
      <address>
        <city>Hat Yai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khon Kaen University Hospital</name>
      <address>
        <city>Khon Kaen</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
    <country>Thailand</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>January 8, 2013</last_update_submitted>
  <last_update_submitted_qc>January 8, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy, term, Asian infants</keyword>
  <keyword>Infant formula</keyword>
  <!-- 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/NCT01681355
org study id: BLU.1.C/A
nct id: NCT01681355
lead sponsor: 
has dmc: No
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula
      in healthy, term, Asian infants.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Gastrointestinal tolerance
time frame: up to Week 6
description: Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.
measure: Anthropometry
time frame: Week 3, Week 6
measure: Use of medication and nutritional supplements
time frame: Week 1, Week 3, Week 6 and Week 8
measure: Number, type and severity of (serious) adverse events
time frame: Week 1, Week 3, Week 6 and Week 8
arm group label: Intervention group
arm group type: Experimental
description: Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition.
intervention type: Other
intervention name: Infant Formula
description: Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition
arm group label: Intervention group
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Jan van der Mooren, PhD
role: Study Director
affiliation: Danone Research
facility: 
facility: 
facility: 
facility: 
facility: 
country: Indonesia
country: Thailand
responsible party type: Sponsor