<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/NCT01727115</url>
  </required_header>
  <id_info>
    <org_study_id>06.04.INF</org_study_id>
    <nct_id>NCT01727115</nct_id>
  </id_info>
  <brief_title>Althera® Versus Nutramigen / Cow's Milk Intolerance</brief_title>
  <official_title>Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in&#xD;
      efficacy than NUTRAMIGEN®&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2008</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">October 2010</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>The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.</measure>
    <time_frame>4 weeks</time_frame>
    <description>regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess whether the 2 groups have comparable changes in weight, length and head circumference</measure>
    <time_frame>1 year</time_frame>
    <description>weight, length, head circumference</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>NUTRAMIGEN®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects are orally fed ad libitum (following guidelines printed on the labels).&#xD;
Subjects will receive the Nutramigen® formula for a 4 week period&#xD;
Then depending of the result of the challenge test we have the following possibilities:&#xD;
If the test is positive: The children continue the formula Nutramigen®&#xD;
If the test is negative: A Follow up formula is given&#xD;
(Nan pro2) if child &gt; 6 months&#xD;
(Nan pro1) if child &lt; 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALTHERA®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are orally fed ad libitum (following guidelines printed on the labels).&#xD;
Subjects will receive the Althera® formula for a 4 week period&#xD;
Then depending of the result of the challenge test we have the following possibilities:&#xD;
If the test is positive: The children continue the formula Althera®&#xD;
If the test is negative: A Follow up formula is given&#xD;
(Nan pro2) if child &gt; 6 months&#xD;
(Nan pro1) if child &lt; 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infant Formula Feeding</intervention_name>
    <description>Assigned formula (Althera® or Nutramigen®) for a 4 weeks period.&#xD;
If the challenge is positive: The children continue the assigned formula&#xD;
If the challenge is negative: A Follow up formula is given&#xD;
(Nan pro2) if child &gt; 6 months&#xD;
(Nan pro1) if child &lt; 6 months</description>
    <arm_group_label>ALTHERA®</arm_group_label>
    <arm_group_label>NUTRAMIGEN®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants from few days of life until 6 months of age&#xD;
&#xD;
          -  Birth weight : between 2.500g and 4.500g&#xD;
&#xD;
          -  Full term: gestational age between 37 and 42 weeks&#xD;
&#xD;
          -  Singleton birth&#xD;
&#xD;
          -  Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI)&#xD;
&#xD;
          -  Having obtained the Informed Consent by the Parents or the legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusive breastfeeding at time of enrolment&#xD;
&#xD;
          -  Having been treated before enrolment with an extensively hydrolysed formula&#xD;
&#xD;
          -  Disease impairing a normal gut transit (like pyloric stenosis)&#xD;
&#xD;
          -  Intolerance to lactose (if already known)&#xD;
&#xD;
          -  Receiving an antibiotic treatment at the time of enrolment&#xD;
&#xD;
          -  Severe or chronic diarrhea&#xD;
&#xD;
          -  Failure to thrive&#xD;
&#xD;
          -  Neurologic diseases&#xD;
&#xD;
          -  Receiving a medical treatment which could interfere with the protocol or after a&#xD;
             surgical intervention&#xD;
&#xD;
          -  Infants whose parents / caregivers who cannot be expected to comply with treatment&#xD;
&#xD;
          -  Currently participating or having participated in another interventional clinical&#xD;
             trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yvan Vandenplas, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>AZ-Kinderen V.U.B.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Hauser, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>AZ-Kinderen V.U.B.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thierry Devreker, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>AZ-Kinderen V.U.B.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Verghote, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Namur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christine Halut, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Namur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olivia Bauraind, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Saint Pierre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sandra Mulier, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU des Enfants Reine Fabiola</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pascal Lenoir, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Notre Dame Tournai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Etienne Sokal, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Universitaire Saint Luc</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francoise Smets, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Universitaire Saint Luc</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francoise Bury, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique de l'Espérance</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stéphanie Colinet, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique de l'Espérance</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefaan Peeters, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalsters Stedelijk ziekenhuis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrick Bollen, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>AZ Vesalius</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Mariën, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sint Augustinus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gigi Veereman, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paola Kinderziekenhuis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Myriam VanWinckel, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Gent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jozef Christens, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maria Ziekenhuis Noord Limburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristien Kamoen, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algemeen Ziekenhuis Maria Middelares</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michèle Scaillon, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU des Enfants Reine Fabiola</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ASZ</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim</name>
      <address>
        <city>Antwerp</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Huderf</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ VUB</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent Pediatrie</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de l'Espérance</name>
      <address>
        <city>Montegnée</city>
        <zip>4420</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Regional</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Pierre</name>
      <address>
        <city>Ottignies</city>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maria Ziekenhuis</name>
      <address>
        <city>Overpelt</city>
        <zip>3900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az Vesalius</name>
      <address>
        <city>Tongeren</city>
        <zip>3700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH WAPI Tournai</name>
      <address>
        <city>Tournai</city>
        <zip>7500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</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>Lactose Intolerance</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727115
org study id: 06.04.INF
nct id: NCT01727115
lead sponsor: 
has dmc: Yes
The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in
      efficacy than NUTRAMIGEN®
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.
time frame: 4 weeks
description: regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms
measure: To assess whether the 2 groups have comparable changes in weight, length and head circumference
time frame: 1 year
description: weight, length, head circumference
arm group label: NUTRAMIGEN®
arm group type: Active Comparator
description: Subjects are orally fed ad libitum (following guidelines printed on the labels).
Subjects will receive the Nutramigen® formula for a 4 week period
Then depending of the result of the challenge test we have the following possibilities:
If the test is positive: The children continue the formula Nutramigen®
If the test is negative: A Follow up formula is given
(Nan pro2) if child > 6 months
(Nan pro1) if child < 6 months
arm group label: ALTHERA®
arm group type: Experimental
description: Subjects are orally fed ad libitum (following guidelines printed on the labels).
Subjects will receive the Althera® formula for a 4 week period
Then depending of the result of the challenge test we have the following possibilities:
If the test is positive: The children continue the formula Althera®
If the test is negative: A Follow up formula is given
(Nan pro2) if child > 6 months
(Nan pro1) if child < 6 months
intervention type: Other
intervention name: Infant Formula Feeding
description: Assigned formula (Althera® or Nutramigen®) for a 4 weeks period.
If the challenge is positive: The children continue the assigned formula
If the challenge is negative: A Follow up formula is given
(Nan pro2) if child > 6 months
(Nan pro1) if child < 6 months
arm group label: ALTHERA®
arm group label: NUTRAMIGEN®
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Yvan Vandenplas, Professor
role: Principal Investigator
affiliation: AZ-Kinderen V.U.B.
last name: Bruno Hauser, Doctor
role: Principal Investigator
affiliation: AZ-Kinderen V.U.B.
last name: Thierry Devreker, Doctor
role: Principal Investigator
affiliation: AZ-Kinderen V.U.B.
last name: Marc Verghote, Doctor
role: Principal Investigator
affiliation: CHR Namur
last name: Christine Halut, Doctor
role: Principal Investigator
affiliation: CHR Namur
last name: Olivia Bauraind, Doctor
role: Principal Investigator
affiliation: Clinique Saint Pierre
last name: Sandra Mulier, Doctor
role: Principal Investigator
affiliation: CHU des Enfants Reine Fabiola
last name: Pascal Lenoir, Doctor
role: Principal Investigator
affiliation: Clinique Notre Dame Tournai
last name: Etienne Sokal, Professor
role: Principal Investigator
affiliation: Clinique Universitaire Saint Luc
last name: Francoise Smets, Doctor
role: Principal Investigator
affiliation: Clinique Universitaire Saint Luc
last name: Francoise Bury, Doctor
role: Principal Investigator
affiliation: Clinique de l'Espérance
last name: Stéphanie Colinet, Doctor
role: Principal Investigator
affiliation: Clinique de l'Espérance
last name: Stefaan Peeters, Doctor
role: Principal Investigator
affiliation: Aalsters Stedelijk ziekenhuis
last name: Patrick Bollen, Doctor
role: Principal Investigator
affiliation: AZ Vesalius
last name: Paul Mariën, Doctor
role: Principal Investigator
affiliation: Sint Augustinus
last name: Gigi Veereman, Professor
role: Principal Investigator
affiliation: Paola Kinderziekenhuis
last name: Myriam VanWinckel, Professor
role: Principal Investigator
affiliation: UZ Gent
last name: Jozef Christens, Doctor
role: Principal Investigator
affiliation: Maria Ziekenhuis Noord Limburg
last name: Kristien Kamoen, doctor
role: Principal Investigator
affiliation: Algemeen Ziekenhuis Maria Middelares
last name: Michèle Scaillon, Doctor
role: Principal Investigator
affiliation: CHU des Enfants Reine Fabiola
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Lactose Intolerance