<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/NCT03019328</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00095833</org_study_id>
    <secondary_id>1U01AI125290</secondary_id>
    <nct_id>NCT03019328</nct_id>
  </id_info>
  <brief_title>Early Peanut Introduction: Translation to Clinical Practice</brief_title>
  <acronym>EPI</acronym>
  <official_title>Early Peanut Introduction: Translation to Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is&#xD;
      a major step towards prevention of food allergy. However, because that finding was from a&#xD;
      clinical trial in a very select population, there are several major questions that must be&#xD;
      answered in order to implement these findings into clinical practice without causing more&#xD;
      harm than good. These questions include who, if anyone, should be screened prior to early&#xD;
      introduction for peanut allergy, how this screening should be done, and what quantity of&#xD;
      peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer&#xD;
      these critical questions so that the potential of these recent findings can be realized. To&#xD;
      that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be&#xD;
      given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of&#xD;
      peanut IgE, and then will be followed for assessment of peanut consumption and development of&#xD;
      peanut allergy until 3 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective&#xD;
      observational study. All subjects will have a baseline research clinic visit, where they will&#xD;
      be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement&#xD;
      of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants&#xD;
      will be advised to begin introducing peanut following the current practice guidelines.&#xD;
      Participants will then be followed until 30 months of age with two clinic visits and regular&#xD;
      monitoring of peanut consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">March 24, 2023</completion_date>
  <primary_completion_date type="Actual">October 31, 2022</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>Percent of infants with peanut allergy at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Percentage of infants who fail the peanut challenge at the baseline visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants</measure>
    <time_frame>baseline</time_frame>
    <description>Results of peanut skin prick tests compared to peanut challenge among the high risk infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants</measure>
    <time_frame>baseline</time_frame>
    <description>Results of anti-peanut IgE testing compared to peanut challenge among the high risk infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants</measure>
    <time_frame>baseline</time_frame>
    <description>Results of anti-Ara h2 IgE testing compared to peanut challenge among the high risk infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of infants who develop peanut allergy by age 30 months</measure>
    <time_frame>30 months</time_frame>
    <description>Percent of infants at risk who develop peanut allergy during the study window (30 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy</measure>
    <time_frame>30 months</time_frame>
    <description>Percent of infants with a positive skin prick test who develop peanut allergy during the study window (30 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peanut levels in bedroom dust as measured by home dust collection</measure>
    <time_frame>18 months</time_frame>
    <description>Peanut levels will be tested by Elisa in bed dust collected by patients using a DUSTREAM(R) vacuum adaptor.</description>
  </secondary_outcome>
  <enrollment type="Actual">333</enrollment>
  <condition>Peanut Allergy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peanut in diet</intervention_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bloods, skin swabs, skin tape strips&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Infants age 4 monhts to 11 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants age 4-11 months&#xD;
&#xD;
          -  Have at least one of the following criteria:&#xD;
&#xD;
               1. physician diagnosis of milk, egg or other non-peanut food allergy,&#xD;
&#xD;
               2. at least moderate eczema as defined by a SCORAD score of at least 25 on present&#xD;
                  or previous evaluation, OR a rash that required the application of topical creams&#xD;
                  or ointments containing corticosteroids or calcineurin inhibitors and occurred on&#xD;
                  at least 7 days on two separate occasions, or is described by the parent or&#xD;
                  guardian as &quot;a bad rash in joints or creases&quot; or &quot;a bad itchy, dry, oozing or&#xD;
                  crusted rash&quot;.&#xD;
&#xD;
               3. a first degree relative (parents or siblings) with either a physician diagnosis&#xD;
                  of IgE mediated peanut allergy OR reported history of symptoms consistent with&#xD;
                  IgE mediated peanut allergy (onset of symptoms within 2 hours of exposure, AND&#xD;
                  symptoms of urticaria, angioedema, wheezing, vomiting, or abdominal pain with&#xD;
                  exposure, AND no subsequent exposure to peanut without symptoms).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of feeding problems&#xD;
&#xD;
          -  History of eosinophilic gastro-intestinal disease&#xD;
&#xD;
          -  Significant medical history (aside from eczema, food allergy or history of wheeze)&#xD;
&#xD;
          -  History of peanut reactions or tolerance prior to baseline screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>11 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corinne Keet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Wood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>peanut allergy</keyword>
  <keyword>food allergens</keyword>
  <keyword>atopic dermatitis</keyword>
  <keyword>eczema</keyword>
  <keyword>infant food allergy testing</keyword>
  <keyword>skin prick testing</keyword>
  <keyword>peanut IgE</keyword>
  <keyword>early peanut introduction</keyword>
  <keyword>food allergy prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Peanut 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/NCT03019328
org study id: IRB00095833
secondary id: 1U01AI125290
nct id: NCT03019328
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is
      a major step towards prevention of food allergy. However, because that finding was from a
      clinical trial in a very select population, there are several major questions that must be
      answered in order to implement these findings into clinical practice without causing more
      harm than good. These questions include who, if anyone, should be screened prior to early
      introduction for peanut allergy, how this screening should be done, and what quantity of
      peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer
      these critical questions so that the potential of these recent findings can be realized. To
      that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be
      given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of
      peanut IgE, and then will be followed for assessment of peanut consumption and development of
      peanut allergy until 3 years of age.
400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective
      observational study. All subjects will have a baseline research clinic visit, where they will
      be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement
      of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants
      will be advised to begin introducing peanut following the current practice guidelines.
      Participants will then be followed until 30 months of age with two clinic visits and regular
      monitoring of peanut consumption.
observational model: Cohort
time perspective: Prospective
measure: Percent of infants with peanut allergy at baseline
time frame: Baseline
description: Percentage of infants who fail the peanut challenge at the baseline visit
measure: Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants
time frame: baseline
description: Results of peanut skin prick tests compared to peanut challenge among the high risk infants
measure: Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants
time frame: baseline
description: Results of anti-peanut IgE testing compared to peanut challenge among the high risk infants
measure: Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants
time frame: baseline
description: Results of anti-Ara h2 IgE testing compared to peanut challenge among the high risk infants
measure: Percent of infants who develop peanut allergy by age 30 months
time frame: 30 months
description: Percent of infants at risk who develop peanut allergy during the study window (30 months)
measure: Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy
time frame: 30 months
description: Percent of infants with a positive skin prick test who develop peanut allergy during the study window (30 months)
measure: Peanut levels in bedroom dust as measured by home dust collection
time frame: 18 months
description: Peanut levels will be tested by Elisa in bed dust collected by patients using a DUSTREAM(R) vacuum adaptor.
intervention type: Other
intervention name: Peanut in diet
Bloods, skin swabs, skin tape strips
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Months
maximum age: 11 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Corinne Keet, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Robert Wood, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Peanut Hypersensitivity
sharing ipd: No