<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/NCT03307122</url>
  </required_header>
  <id_info>
    <org_study_id>17.01.US.INF</org_study_id>
    <nct_id>NCT03307122</nct_id>
  </id_info>
  <brief_title>Gastrointestinal Tolerance Evaluation of an Infant Formula</brief_title>
  <official_title>Infant Formula GI Tolerance Evaluation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, double-blind, randomized study of 2 infant formulas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exclusively formula-fed infants will participate in a 6-week feeding period of an infant&#xD;
      formula. Tolerance records will be kept for 2 days at the end of the 6-week period by&#xD;
      caregivers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">January 19, 2018</completion_date>
  <primary_completion_date type="Actual">January 19, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant GI Symptom Burden</measure>
    <time_frame>6 weeks</time_frame>
    <description>Study personnel will administer questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stool pattern</measure>
    <time_frame>6 weeks</time_frame>
    <description>Caregivers will document on diary records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spit-up and/or vomiting pattern</measure>
    <time_frame>6 weeks</time_frame>
    <description>Caregivers will document on diary records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crying and fussing duration</measure>
    <time_frame>6 weeks</time_frame>
    <description>Caregivers will document on diary records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Formula intake</measure>
    <time_frame>6 weeks</time_frame>
    <description>Caregivers will document on diary records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Formula satisfaction questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>Study personnel will administer questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (measured in grams)</measure>
    <time_frame>Enrollment and 6 weeks</time_frame>
    <description>Study personnel will measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length (measured in centimeters)</measure>
    <time_frame>Enrollment and 6 weeks</time_frame>
    <description>Study personnel will measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 weeks and 6 weeks</time_frame>
    <description>Assessed throughout study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Healthy, Full-term Infants Who Are Formula-fed</condition>
  <arm_group>
    <arm_group_label>Routine Infant Formula 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine infant formula with probiotic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Infant Formula 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine infant formula with probiotic and prebiotic</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine Infant Formula 1</intervention_name>
    <description>Routine infant formula with probiotic</description>
    <arm_group_label>Routine Infant Formula 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine Infant Formula 2</intervention_name>
    <description>Routine infant formula with probiotic and prebiotic</description>
    <arm_group_label>Routine Infant Formula 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy newborn singleton infant&#xD;
&#xD;
          -  Full-term (&gt; 37 weeks gestation)&#xD;
&#xD;
          -  Birth weight ≥ 2500 grams and ≤ 4500 grams&#xD;
&#xD;
          -  9-19 days of age on enrollment&#xD;
&#xD;
          -  Infant's mother has elected not to breastfeed prior to enrollment and infant has&#xD;
             exclusively formula-fed for at least 3days prior to enrollment&#xD;
&#xD;
          -  Having obtained his/her legal representative's informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected cow-milk allergy&#xD;
&#xD;
          -  Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino&#xD;
             acid-based, metabolic), or soy-based or lactose free infant formula&#xD;
&#xD;
          -  Currently not tolerating (as perceived by the caregiver) their formula&#xD;
&#xD;
          -  Currently being treated for reflux&#xD;
&#xD;
          -  Currently experiencing gastrointestinal or respiratory symptoms secondary to an&#xD;
             on-going infection or virus (e.g. gastrointestinal infection, upper respiratory&#xD;
             infection, flu)&#xD;
&#xD;
          -  Congenital illness or malformation that may affect infant feeding and/or growth&#xD;
&#xD;
          -  Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment&#xD;
&#xD;
          -  Receiving prescription medication (with exception of treatment for thrush or topical&#xD;
             medications) or home remedies, herbal preparations, or rehydration fluids that might&#xD;
             affect GI tolerance (vitamin and mineral supplements excepted).&#xD;
&#xD;
          -  Infant's family who in the Investigator's assessment cannot be expected to comply with&#xD;
             treatment (feeding regimen).&#xD;
&#xD;
          -  Participation in another study that has not been approved as a concomitant study by&#xD;
             Nestlé Nutrition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Days</minimum_age>
    <maximum_age>19 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Carvalho, MD</last_name>
    <role>Study Director</role>
    <affiliation>Nestle Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avanza Medical Research Center</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bluegrass Clinical Research, Inc.</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PediaResearch</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Pediatric Research Association</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Associates</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midsouth Center for Clinical Research, LLC</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Children's Research Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tanner Clinic</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03307122
org study id: 17.01.US.INF
nct id: NCT03307122
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, double-blind, randomized study of 2 infant formulas.
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant
      formula. Tolerance records will be kept for 2 days at the end of the 6-week period by
      caregivers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Infant GI Symptom Burden
time frame: 6 weeks
description: Study personnel will administer questionnaire
measure: Stool pattern
time frame: 6 weeks
description: Caregivers will document on diary records
measure: Spit-up and/or vomiting pattern
time frame: 6 weeks
description: Caregivers will document on diary records
measure: Crying and fussing duration
time frame: 6 weeks
description: Caregivers will document on diary records
measure: Formula intake
time frame: 6 weeks
description: Caregivers will document on diary records
measure: Formula satisfaction questionnaire
time frame: 6 weeks
description: Study personnel will administer questionnaire
measure: Weight (measured in grams)
time frame: Enrollment and 6 weeks
description: Study personnel will measure
measure: Length (measured in centimeters)
time frame: Enrollment and 6 weeks
description: Study personnel will measure
measure: Adverse events
time frame: 2 weeks and 6 weeks
description: Assessed throughout study
arm group label: Routine Infant Formula 1
arm group type: Active Comparator
description: Routine infant formula with probiotic
arm group label: Routine Infant Formula 2
arm group type: Active Comparator
description: Routine infant formula with probiotic and prebiotic
intervention type: Other
intervention name: Routine Infant Formula 1
description: Routine infant formula with probiotic
arm group label: Routine Infant Formula 1
intervention type: Other
intervention name: Routine Infant Formula 2
description: Routine infant formula with probiotic and prebiotic
arm group label: Routine Infant Formula 2
criteria: 
gender: All
minimum age: 9 Days
maximum age: 19 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Ryan Carvalho, MD
role: Study Director
affiliation: Nestle Nutrition
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No