<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/NCT01684319</url>
  </required_header>
  <id_info>
    <org_study_id>11-202 (MATPED 11-047)</org_study_id>
    <nct_id>NCT01684319</nct_id>
  </id_info>
  <brief_title>Milk-induced Gastrointestinal Symptoms in Infants</brief_title>
  <official_title>Prospective, Randomized, Double Blind and Placebo Controlled Study With the Aim to Establish the Role of Milk Proteins in Gastrointestinal Diseases (GERD, Constipation and Colics) of Young Infants and to Determine the Diagnostic Value of Immunological Tests in These Pathologies.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Various digestive manifestations are common in infants less than 6 months and have a&#xD;
      significant impact on morbidity and quality of life of the family. In a prospective study on&#xD;
      more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of&#xD;
      these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%),&#xD;
      constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate,&#xD;
      and their cause is often difficult to determine. Frequently, the pediatrician will exclude&#xD;
      cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked.&#xD;
      This measure causes significant additional costs through the use of extensively hydrolyzed&#xD;
      milk specifically for children and involves an elimination diet of all foods containing cow's&#xD;
      milk sometimes for several years. This can negatively influence the growth of the child.&#xD;
&#xD;
      If the involvement of milk in these pathologies is suggested by some early studies (35% for&#xD;
      colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current&#xD;
      state of knowledge if these gastrointestinal symptoms are actually due to an &quot;allergy&quot; to&#xD;
      milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy.&#xD;
      However, various tests have proven their effectiveness in the investigation of non&#xD;
      IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Milk allergy in gastrointestinal diseases in young infants</measure>
    <time_frame>10 weeks</time_frame>
    <description>Establish the role of milk proteins in gastrointestinal diseases in young infants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic tests</measure>
    <time_frame>10 weeks</time_frame>
    <description>Determine the diagnostic value of immunological tests in these pathologies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Gastrointestinal Symptoms in Young Infants</condition>
  <arm_group>
    <arm_group_label>Infant formula milk</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Infant formula milk adapted to age of infant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formula milk free of milk proteins</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Milk-free formula milk adapted to age of infant</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Formula milk free of cow's milk protein</intervention_name>
    <arm_group_label>Formula milk free of milk proteins</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Infant formula milk</description>
    <arm_group_label>Infant formula milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants 0-6 month old with at least one of the following symptoms : constipation,&#xD;
             gastroesophageal reflux, colics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prematurity&#xD;
&#xD;
          -  exclusive breastfeeding&#xD;
&#xD;
          -  Other cause for symptoms&#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>Philippe A Eigenmann, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hôpitaux Unversitaire de Genève</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève</name>
      <address>
        <city>Genève</city>
        <state>GE</state>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>January 3, 2014</last_update_submitted>
  <last_update_submitted_qc>January 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Philippe Eigenmann</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Constipation</keyword>
  <keyword>Gastroeosphageal reflux</keyword>
  <keyword>Colics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caseins</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>May 18, 2022</submitted>
    <returned>February 16, 2023</returned>
  </pending_results>
  <!-- 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/NCT01684319
org study id: 11-202 (MATPED 11-047)
nct id: NCT01684319
lead sponsor: 
has dmc: No
Various digestive manifestations are common in infants less than 6 months and have a
      significant impact on morbidity and quality of life of the family. In a prospective study on
      more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of
      these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%),
      constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate,
      and their cause is often difficult to determine. Frequently, the pediatrician will exclude
      cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked.
      This measure causes significant additional costs through the use of extensively hydrolyzed
      milk specifically for children and involves an elimination diet of all foods containing cow's
      milk sometimes for several years. This can negatively influence the growth of the child.

      If the involvement of milk in these pathologies is suggested by some early studies (35% for
      colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current
      state of knowledge if these gastrointestinal symptoms are actually due to an "allergy" to
      milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy.
      However, various tests have proven their effectiveness in the investigation of non
      IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Milk allergy in gastrointestinal diseases in young infants
time frame: 10 weeks
description: Establish the role of milk proteins in gastrointestinal diseases in young infants
measure: Diagnostic tests
time frame: 10 weeks
description: Determine the diagnostic value of immunological tests in these pathologies
arm group label: Infant formula milk
arm group type: Placebo Comparator
description: Infant formula milk adapted to age of infant
arm group label: Formula milk free of milk proteins
arm group type: Active Comparator
description: Milk-free formula milk adapted to age of infant
intervention type: Dietary Supplement
intervention name: Formula milk free of cow's milk protein
arm group label: Formula milk free of milk proteins
intervention type: Dietary Supplement
intervention name: Placebo
description: Infant formula milk
arm group label: Infant formula milk
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Philippe A Eigenmann, MD
role: Study Director
affiliation: Hôpitaux Unversitaire de Genève
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Philippe Eigenmann
investigator title: Professor
mesh term: Constipation
mesh term: Caseins
submitted: May 18, 2022
returned: February 16, 2023