<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/NCT03769051</url>
  </required_header>
  <id_info>
    <org_study_id>20180402 v1.3</org_study_id>
    <nct_id>NCT03769051</nct_id>
  </id_info>
  <brief_title>Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula</brief_title>
  <official_title>Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      The main purpose of this study was to observe the effect of amino acid formula on infants&#xD;
      with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food&#xD;
      Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the&#xD;
      allergic process in infants with cow's milk protein allergy and to explore the criteria for&#xD;
      diagnosis and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects.&#xD;
      The suitable subject will be enrolled and there are seven visits through the 6-month study.&#xD;
      Efficacy parameters are the positive incidence of open food challenge test, growth and&#xD;
      development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms&#xD;
      (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2015</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Negative rate of open food challenge test</measure>
    <time_frame>From baseline to AAF feeding for 6 months</time_frame>
    <description>Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WAZ(weight for age Z score)</measure>
    <time_frame>From baseline to AAF feeding for 6 months</time_frame>
    <description>Z-scores of anthropometric parameters from baseline on weight=Average(The difference between the measured infant weight and the reference infant weight of the same age and sex/the reference infant weight standard deviation) The increase of WAZ indicated that AAF could promote growth and development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAZ(height for age Z score)</measure>
    <time_frame>From baseline until AAF feeding for 6 months</time_frame>
    <description>Z-scores of anthropometric parameters from baseline on height=Average(The difference between the measured infant height and the reference infant height of the same age and sex/the reference infant height standard deviation) The increase of HAZ indicated that AAF could promote growth and development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCAZ(head circumference for age Z score)</measure>
    <time_frame>From baseline to AAF feeding for 6 months</time_frame>
    <description>Z-scores of anthropometric parameters from baseline on head circumference=Average(The difference between the measured infant head circumference and the reference infant head circumference of the same age and sex/the reference infant head circumference standard deviation) The increase of HCAZ indicated that AAF could promote growth and development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCORAD score</measure>
    <time_frame>From baseline to AAF feeding for 6 months</time_frame>
    <description>An SCORAD evaluation scale was evaluated by the investigator at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptom score</measure>
    <time_frame>From baseline to AAF feeding for 6 months</time_frame>
    <description>An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory symptom score</measure>
    <time_frame>From baseline to AAF feeding for 6 months</time_frame>
    <description>An Respiratory symptom evaluation scale was evaluated by the investigator at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort symptom score</measure>
    <time_frame>From baseline to AAF feeding for 6 months</time_frame>
    <description>An Comfort symptom evaluation scale was evaluated by the investigator at each visit</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Cow's Milk Protein Allergy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cow's milk protein allergy infants in 0~6 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 0 to 6 months;&#xD;
&#xD;
          -  Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin,&#xD;
             gastrointestinal tract, respiratory tract or comfortable tract)&#xD;
&#xD;
          -  Unable to breastfeed;&#xD;
&#xD;
          -  Vital signs are stable;&#xD;
&#xD;
          -  Legal guardian has signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with congenital and hereditary metabolic diseases;&#xD;
&#xD;
          -  Digestive tract obstruction;&#xD;
&#xD;
          -  Subject with immunodeficiency diseases;&#xD;
&#xD;
          -  Subject who is allergic to known components of amino acid formula powder;&#xD;
&#xD;
          -  The investigator judges it is not suitable for the subject to participate in this&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Zhang</last_name>
    <role>Study Director</role>
    <affiliation>Colleague</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>September 1, 2019</last_update_submitted>
  <last_update_submitted_qc>September 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cow's Milk Protein allergy</keyword>
  <keyword>Open Food Challenge test</keyword>
  <keyword>Immune Tolerance</keyword>
  <keyword>Amino Acid Formula</keyword>
  <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>Undecided</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/NCT03769051
org study id: 20180402 v1.3
nct id: NCT03769051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study was to observe the effect of amino acid formula on infants
      with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food
      Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the
      allergic process in infants with cow's milk protein allergy and to explore the criteria for
      diagnosis and treatment.
This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects.
      The suitable subject will be enrolled and there are seven visits through the 6-month study.
      Efficacy parameters are the positive incidence of open food challenge test, growth and
      development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms
      (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).
observational model: Cohort
time perspective: Prospective
measure: Negative rate of open food challenge test
time frame: From baseline to AAF feeding for 6 months
description: Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF
measure: WAZ(weight for age Z score)
time frame: From baseline to AAF feeding for 6 months
description: Z-scores of anthropometric parameters from baseline on weight=Average(The difference between the measured infant weight and the reference infant weight of the same age and sex/the reference infant weight standard deviation) The increase of WAZ indicated that AAF could promote growth and development.
measure: HAZ(height for age Z score)
time frame: From baseline until AAF feeding for 6 months
description: Z-scores of anthropometric parameters from baseline on height=Average(The difference between the measured infant height and the reference infant height of the same age and sex/the reference infant height standard deviation) The increase of HAZ indicated that AAF could promote growth and development.
measure: HCAZ(head circumference for age Z score)
time frame: From baseline to AAF feeding for 6 months
description: Z-scores of anthropometric parameters from baseline on head circumference=Average(The difference between the measured infant head circumference and the reference infant head circumference of the same age and sex/the reference infant head circumference standard deviation) The increase of HCAZ indicated that AAF could promote growth and development.
measure: SCORAD score
time frame: From baseline to AAF feeding for 6 months
description: An SCORAD evaluation scale was evaluated by the investigator at each visit
measure: Gastrointestinal symptom score
time frame: From baseline to AAF feeding for 6 months
description: An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit
measure: Respiratory symptom score
time frame: From baseline to AAF feeding for 6 months
description: An Respiratory symptom evaluation scale was evaluated by the investigator at each visit
measure: Comfort symptom score
time frame: From baseline to AAF feeding for 6 months
description: An Comfort symptom evaluation scale was evaluated by the investigator at each visit
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 6 Months
healthy volunteers: No
last name: Juan Zhang
role: Study Director
affiliation: Colleague
responsible party type: Sponsor
mesh term: Milk Hypersensitivity
sharing ipd: Undecided