<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/NCT01715246</url>
  </required_header>
  <id_info>
    <org_study_id>11.26.INF</org_study_id>
    <nct_id>NCT01715246</nct_id>
  </id_info>
  <brief_title>Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)</brief_title>
  <official_title>Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)</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 primary objective of this clinical study is to show that infants fed a standard starter&#xD;
      infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants&#xD;
      fed a standard starter infant formula without HMOs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Growth</measure>
    <time_frame>4 months of life</time_frame>
    <description>child growth (body weight) from enrollment to 4 months of age</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>6 and 12 months of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)</measure>
    <time_frame>every month during 6 months</time_frame>
    <description>Parents are asked to complete a diary on digistive tolerance of their child</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Product compliance (quantity of formula in ml consumed on the 3 days before visit)</measure>
    <time_frame>every month for 6 months</time_frame>
    <description>Parents are asked to complete a diary on the product compliance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>ongoing for 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool microbiota</measure>
    <time_frame>3 and 12 months of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene expression</measure>
    <time_frame>3 and 12 months of age</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Starter infant formula without HMO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Volumes of feed depend on age, weight and appetite.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Starter infant formula with 2 HMOs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Volumes of feeds depend on age, weight and appetite</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breasfed reference group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infant Formula</intervention_name>
    <arm_group_label>Starter infant formula with 2 HMOs</arm_group_label>
    <arm_group_label>Starter infant formula without HMO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy babies&#xD;
&#xD;
          -  Full term babies (37 weeks ≤ gestation ≤ 42 weeks)&#xD;
&#xD;
          -  birth weight between 2500 g- 4500g&#xD;
&#xD;
          -  Having obtained the baby's legal representative's informed consent.&#xD;
&#xD;
          -  FF groups:&#xD;
&#xD;
        babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose&#xD;
        mother independently elected, before enrollment, not to breastfeed&#xD;
&#xD;
        • BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital illness or malformation that may affect growth&#xD;
&#xD;
          -  Significant pre-natal and/or serious post-natal disease before enrollment (by medical&#xD;
             decision)&#xD;
&#xD;
          -  Minor parent(s)&#xD;
&#xD;
          -  Newborn whose parents / caregivers cannot be expected to comply with study procedures&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial since birth,&#xD;
             except for BF group, where vaccines studies are allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>14 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giovanni CORSELLO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dipartimento Materno Infantile, Palermo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philippe ALLIET</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kinderartsenpraktijk, Hasselt, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kinderartsenpraktijk</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento Materno Infantile</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>September 10, 2015</last_update_submitted>
  <last_update_submitted_qc>September 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>healthy babbies</keyword>
  <keyword>infant formula</keyword>
  <keyword>growth</keyword>
  <keyword>HMO</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/NCT01715246
org study id: 11.26.INF
nct id: NCT01715246
lead sponsor: 
has dmc: No
The primary objective of this clinical study is to show that infants fed a standard starter
      infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants
      fed a standard starter infant formula without HMOs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Growth
time frame: 4 months of life
description: child growth (body weight) from enrollment to 4 months of age
measure: Growth
time frame: 6 and 12 months of age
measure: Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)
time frame: every month during 6 months
description: Parents are asked to complete a diary on digistive tolerance of their child
measure: Product compliance (quantity of formula in ml consumed on the 3 days before visit)
time frame: every month for 6 months
description: Parents are asked to complete a diary on the product compliance
measure: Morbidity
time frame: ongoing for 1 year
measure: Stool microbiota
time frame: 3 and 12 months of age
measure: Gene expression
time frame: 3 and 12 months of age
arm group label: Starter infant formula without HMO
arm group type: Placebo Comparator
description: Volumes of feed depend on age, weight and appetite.
arm group label: Starter infant formula with 2 HMOs
arm group type: Active Comparator
description: Volumes of feeds depend on age, weight and appetite
arm group label: Breasfed reference group
arm group type: No Intervention
intervention type: Other
intervention name: Infant Formula
arm group label: Starter infant formula with 2 HMOs
arm group label: Starter infant formula without HMO
criteria: 
gender: All
minimum age: N/A
maximum age: 14 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Giovanni CORSELLO
role: Principal Investigator
affiliation: Dipartimento Materno Infantile, Palermo
last name: Philippe ALLIET
role: Principal Investigator
affiliation: Kinderartsenpraktijk, Hasselt, Belgium
facility: 
facility: 
country: Belgium
country: Italy
responsible party type: Sponsor