<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/NCT03236207</url>
  </required_header>
  <id_info>
    <org_study_id>16.16.CLI</org_study_id>
    <nct_id>NCT03236207</nct_id>
  </id_info>
  <brief_title>Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula</brief_title>
  <official_title>Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula</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>
      Infants/children with cow's milk allergy will take part in 2 double-blinded&#xD;
      placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random&#xD;
      order. If both food challenges are passed, subjects will be asked to consume the Test formula&#xD;
      in an at-home open challenge for 7 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2017</start_date>
  <completion_date type="Actual">November 6, 2018</completion_date>
  <primary_completion_date type="Actual">November 6, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>allergic reaction post DBPCFC</measure>
    <time_frame>2 hours</time_frame>
    <description>subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stool characteristics</measure>
    <time_frame>1 week</time_frame>
    <description>collected on daily diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>formula intake</measure>
    <time_frame>1 week</time_frame>
    <description>amount of formula ingested daily</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>1 week</time_frame>
    <description>adverse events as reported by caregivers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Cow Milk Allergy</condition>
  <arm_group>
    <arm_group_label>Test infant formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test non-commercial extensively hydrolyzed infant formula with HMOs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control infant formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control non-commercial extensively hydrolyzed infant formula without HMOs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test extensively hydrolyzed formula</intervention_name>
    <description>extensively hydrolyzed formula with HMOs</description>
    <arm_group_label>Test infant formula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control extensively hydrolyzed formula</intervention_name>
    <description>extensively hydrolyzed formula without HMOs</description>
    <arm_group_label>Control infant formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born at term (&gt;36 weeks gestation)&#xD;
&#xD;
          -  2 months to &lt;4 years of age at enrollment&#xD;
&#xD;
          -  Documented CMA within 6 months prior to enrollment&#xD;
&#xD;
          -  Otherwise healthy&#xD;
&#xD;
          -  Having obtained his/her legal representative's informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children consuming mother's milk at the time of inclusion and during the trial&#xD;
&#xD;
          -  Any chromosomal or major congenital anomalies&#xD;
&#xD;
          -  Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems&#xD;
             (heart murmurs okay))&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Anaphylaxis to any food&#xD;
&#xD;
          -  Receiving free amino acid formula&#xD;
&#xD;
          -  Subject who in the Investigator's assessment cannot be expected to adhere to the study&#xD;
             protocol&#xD;
&#xD;
          -  Currently participating in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Nowak-Wegrzyn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mt Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hoag Medical Group</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55441</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Clinical Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Breathe America</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health System</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy, Asthma and Clinical Research Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>71320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina ENT</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memphis &amp; Shelby County Pediatrics</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Clinical Research Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma Research Institute</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76633</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</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>Milk Hypersensitivity</mesh_term>
  </condition_browse>
  <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/NCT03236207
org study id: 16.16.CLI
nct id: NCT03236207
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infants/children with cow's milk allergy will take part in 2 double-blinded
      placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random
      order. If both food challenges are passed, subjects will be asked to consume the Test formula
      in an at-home open challenge for 7 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: allergic reaction post DBPCFC
time frame: 2 hours
description: subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators
measure: stool characteristics
time frame: 1 week
description: collected on daily diaries
measure: formula intake
time frame: 1 week
description: amount of formula ingested daily
measure: adverse events
time frame: 1 week
description: adverse events as reported by caregivers
arm group label: Test infant formula
arm group type: Experimental
description: Test non-commercial extensively hydrolyzed infant formula with HMOs
arm group label: Control infant formula
arm group type: Active Comparator
description: Control non-commercial extensively hydrolyzed infant formula without HMOs
intervention type: Other
intervention name: Test extensively hydrolyzed formula
description: extensively hydrolyzed formula with HMOs
arm group label: Test infant formula
intervention type: Other
intervention name: Control extensively hydrolyzed formula
description: extensively hydrolyzed formula without HMOs
arm group label: Control infant formula
criteria: 
gender: All
minimum age: 2 Months
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Nowak-Wegrzyn, MD
role: Principal Investigator
affiliation: Mt Sinai
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Milk Hypersensitivity
sharing ipd: No