<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/NCT03835767</url>
  </required_header>
  <id_info>
    <org_study_id>190053</org_study_id>
    <secondary_id>19-I-0053</secondary_id>
    <nct_id>NCT03835767</nct_id>
  </id_info>
  <brief_title>Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis</brief_title>
  <official_title>Prospective Study to Identify Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in Patients With Elevated Total Serum IgE Levels and Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Atopic dermatitis (AD), also called eczema, makes skin dry, red, and itchy. People with AD&#xD;
      are more likely to get a food allergy than people without AD. But some food allergy tests are&#xD;
      not always accurate in people with AD. Researchers want to study if people are truly allergic&#xD;
      to milk and/or peanuts.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To improve the ways doctors test for food allergy in people with AD.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People ages 3 21 who have had AD; have a high total IgE level (an allergic antibody); might&#xD;
      have a milk and/or peanut allergy; and are currently enrolled in another NIH study&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened under another protocol.&#xD;
&#xD;
      Participants will have a physical exam, blood tests, and medical history.&#xD;
&#xD;
      Participants will breathe into a plastic device that measures lung strength.&#xD;
&#xD;
      Participants may get a small plastic tube inserted in their arm.&#xD;
&#xD;
      Participants who have not had an allergic reaction to food in the past 3 years will do 1 or&#xD;
      more oral food challenge (OFCs) depending on their allergies.&#xD;
&#xD;
      They will eat a little bit of the food they might be allergic to.&#xD;
&#xD;
      They will be watched for a reaction. If they have one, they will know for sure they are&#xD;
      allergic.&#xD;
&#xD;
      They may keep eating bigger portions of the food until they either have a reaction or finish&#xD;
      all the food.&#xD;
&#xD;
      In some OFCs, participants will get a placebo food.&#xD;
&#xD;
      OFCs will last a few hours or 2 days. Participants will repeat all tests at each OFC.&#xD;
&#xD;
      Participation can last up to 12 months.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allergy skin prick tests and measurement of food-specific immunoglobulin E (IgE) levels are&#xD;
      common but not robust means to diagnose food allergy, so patients may be placed on overly&#xD;
      restrictive food elimination diets as a result of false positive results. Such restrictions&#xD;
      can lead to poor weight gain, malnutrition, and negative impact on quality of life. More than&#xD;
      half of patients who are sensitized (ie, have a positive IgE test) to a particular food do&#xD;
      not react to it during an oral food challenge, the gold standard for diagnosing food allergy.&#xD;
      Development of food allergy does not always correlate to food-specific IgE levels. The care&#xD;
      of these patients would be dramatically improved if decision points for food-specific or&#xD;
      component IgEs could be identified that predict when an immediate hypersensitivity is&#xD;
      present. This is especially an issue among patients with atopic dermatitis (AD), the most&#xD;
      common chronic, relapsing inflammatory disorder of the skin affecting children. Patients with&#xD;
      AD are more likely to develop other allergic conditions, including food allergy and&#xD;
      sensitization. AD patients are also likely to have high levels of total serum IgE.&#xD;
&#xD;
      In this study, participants aged 3-21 years (n = 175) with elevated total serum IgE levels&#xD;
      and a history of AD will undergo open feedings and/or double-blind, placebo-controlled food&#xD;
      challenges (DBPCFCs). Open feedings will be 1- or 2-step, depending on how often the&#xD;
      participant regularly consumes the food at home. There are two DBPCFCs to milk: milk powder&#xD;
      or (placebo) baked into a muffin, and straight milk powder or (placebo) mixed with a vehicle.&#xD;
      The DBPCFC for peanut will be done with peanut flour or (placebo) mixed with a vehicle. Blood&#xD;
      will be collected during the study for measurement of total and component IgEs as well as&#xD;
      potential biomarkers of food sensitization vs. immediate hypersensitivity and reaction&#xD;
      severity. From these data, we hope to identify diagnostic IgE threshold levels that will&#xD;
      inform when oral food challenges are warranted in patients with elevated total serum IgE&#xD;
      levels and AD, which is critically needed in the allergy field to facilitate the care of&#xD;
      these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 19, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date>
  <phase>Phase 2</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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Allergy to milk and peanut status; allowing for estimation of IgE thresholds that determine a subgroup with at least 50% chance of tolerance in patients with elevated total serum IgE levels and history of AD.</measure>
    <time_frame>Oral Food Challenge Visits</time_frame>
    <description>To estimate ROC curves for food specific and component IgE threshold levels in patients with elevated total serum IgE and a history of AD, to determine a subgroup with at least a 50% likelihood of tolerance to peanut and/or milk, via use of oral food challenges, and to estimate other diagnostic metrics (sensitivity and specificity) associated with this 50% risk threshold.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Basophil and mast cell reactivity and other exploratory markers.</measure>
    <time_frame>Oral Food Challenge Visitsv</time_frame>
    <description>To investigate the correlation between food-specific and/or component IgE values and other potential diagnostic tests for food allergy, including in vitro basophil and/or mast cell activation tests.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Milk and/or Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>Milk DBPCFC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There are two double blind placebo controlled food challenges. The first challenge is to baked milk. The following participants will undergo this DBPCFC: - All participants who eat baked milk less than once per month. - Participants who never eat baked milk or straight milk. On the first day of this challenge, participants will be randomized to either milk Baked milk or rice milk. Dry milk powder or corn starch. or placebo, and then will be challenged with the other food on the next day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One-Step Open Feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who are consuming baked milk, straight milk, and/or peanut products at least once per week will do a one-step oral food challenge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peanut DBPCFC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The DBPCFC for peanut allergy will be done with either peanut flour or a placebo (oat flour). The following participants will undergo this DBPCFC: - All participants who eat peanut less than once per month - Participants who never eat peanut On the first day of this challenge, participants will be randomized to either peanut or placebo, and then will be challenged with the other food on the next day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two-Step Open Feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who consume baked milk, straight milk, and/or peanut products less than once per week but at least once per month will do a two step open oral food challenge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peanut powder and Oat flour</intervention_name>
    <description>Peanut powder with 46% protein content is manufactured by PB2. Oat flour is manufactured by GF Harvest.</description>
    <arm_group_label>One-Step Open Feeding</arm_group_label>
    <arm_group_label>Peanut DBPCFC</arm_group_label>
    <arm_group_label>Two-Step Open Feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peanut flour and Oat flour (placebo for peanut flour)</intervention_name>
    <description>Peanut flour (12% light roast) with 50% protein content is manufactured by Byrd Mill. Oat flour is manufactured by GF Harvest.</description>
    <arm_group_label>One-Step Open Feeding</arm_group_label>
    <arm_group_label>Peanut DBPCFC</arm_group_label>
    <arm_group_label>Two-Step Open Feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Milk Powder and Corn Starch (placebo for Milk powder)</intervention_name>
    <description>Dry milk powder with 36% protein content is manufactured by Giant Food. Corn starch is Argo brand.</description>
    <arm_group_label>Milk DBPCFC</arm_group_label>
    <arm_group_label>One-Step Open Feeding</arm_group_label>
    <arm_group_label>Two-Step Open Feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baked milk and Rice milk (placebo for Baked milk)</intervention_name>
    <description>Baked milk will be in the form of a muffin provided by the NIH CC Nutrition Department. Rice milk is manufactured by Rice Dream brand.</description>
    <arm_group_label>Milk DBPCFC</arm_group_label>
    <arm_group_label>One-Step Open Feeding</arm_group_label>
    <arm_group_label>Two-Step Open Feeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Individuals must meet all of the following criteria to be eligible for study participation:&#xD;
&#xD;
          1. Aged 3-21 years.&#xD;
&#xD;
          2. Currently enrolled on study 15-I-0162, Natural History and Genetics of Food Allergy&#xD;
             and Related Conditions.&#xD;
&#xD;
          3. Has a total serum IgE level greater than or equal to 1000 kU/L at time of screening.&#xD;
&#xD;
          4. Has a history of AD based on self-report or physician assessment.&#xD;
&#xD;
          5. Willing to undergo an oral food challenge to both placebo and test food.&#xD;
&#xD;
          6. Willing to allow storage of blood samples for future use in medical research.&#xD;
&#xD;
          7. Willing to allow genetic testing to be conducted on blood samples.&#xD;
&#xD;
          8. Has a primary care physician or other physician who will manage all health conditions&#xD;
             related or unrelated to the study objectives.&#xD;
&#xD;
          9. Be willing to discontinue omalizumab or dupilumab within 6 months of a food&#xD;
             challenge,and antihistamines and oral steroids prior to a food challenge, as these&#xD;
             drugs might interfere with the oral food challenge procedure. Use of topical steroids&#xD;
             will be allowed&#xD;
&#xD;
         10. Able to provide informed consent.&#xD;
&#xD;
        EXCLUSION CRITIERIA:&#xD;
&#xD;
        Individuals meeting any of the following criteria will be excluded from study&#xD;
        participation:&#xD;
&#xD;
          1. Pregnant.&#xD;
&#xD;
          2. Known genetic disorder that causes an elevation in total IgE level or one that could&#xD;
             affect the severity of an anaphylactic response.&#xD;
&#xD;
          3. Known cardiac disease.&#xD;
&#xD;
          4. Current use of a beta-blocker.&#xD;
&#xD;
          5. Active eosinophilic gastrointestinal (GI) disorder including eosinophilic esophagitis,&#xD;
             currently symptomatic, unless they are currently on treatment and have had a negative&#xD;
             esophageal biopsy via endoscopy within at least the past 18 months, and/or unless the&#xD;
             study food is already in the participants diets.&#xD;
&#xD;
          6. Any chronic medical condition requiring long-term use of oral steroids&#xD;
&#xD;
          7. Current or recent (within previous 6 months) use of omalizumab or dupilumab.&#xD;
&#xD;
          8. Any condition that, in the opinion of the investigator, contraindicates participation&#xD;
             in this study.&#xD;
&#xD;
        Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than&#xD;
        enrollment on observational studies. Consideration for co-enrollment in trials evaluating&#xD;
        the use of a licensed medication will require the approval of the principal investigator.&#xD;
        Study staff should be notified of co-enrollment on any other protocol as it may require the&#xD;
        approval of the principal investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernanda D Young, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ellen Zektser, R.N.</last_name>
    <phone>(301) 761-7565</phone>
    <email>ellen.zektser@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fernanda D Young, M.D.</last_name>
    <phone>(301) 761-6629</phone>
    <email>youngfd@nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY8664111010</phone_ext>
      <email>prpl@cc.nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2019-I-0053.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Fleischer DM, Bock SA, Spears GC, Wilson CG, Miyazawa NK, Gleason MC, Gyorkos EA, Murphy JR, Atkins D, Leung DY. Oral food challenges in children with a diagnosis of food allergy. J Pediatr. 2011 Apr;158(4):578-583.e1. doi: 10.1016/j.jpeds.2010.09.027. Epub 2010 Oct 28.</citation>
    <PMID>21030035</PMID>
  </reference>
  <reference>
    <citation>Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma &amp; Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.</citation>
    <PMID>23195525</PMID>
  </reference>
  <reference>
    <citation>Franxman TJ, Howe L, Teich E, Greenhawt MJ. Oral food challenge and food allergy quality of life in caregivers of children with food allergy. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):50-6. doi: 10.1016/j.jaip.2014.06.016. Epub 2014 Aug 29.</citation>
    <PMID>25577618</PMID>
  </reference>
  <verification_date>August 17, 2023</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>August 19, 2023</last_update_submitted>
  <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Food Challenge</keyword>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Milk</keyword>
  <keyword>Peanut</keyword>
  <keyword>Food Allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
    <mesh_term>Peanut Hypersensitivity</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/NCT03835767
org study id: 190053
secondary id: 19-I-0053
nct id: NCT03835767
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Atopic dermatitis (AD), also called eczema, makes skin dry, red, and itchy. People with AD
      are more likely to get a food allergy than people without AD. But some food allergy tests are
      not always accurate in people with AD. Researchers want to study if people are truly allergic
      to milk and/or peanuts.

      Objectives:

      To improve the ways doctors test for food allergy in people with AD.

      Eligibility:

      People ages 3 21 who have had AD; have a high total IgE level (an allergic antibody); might
      have a milk and/or peanut allergy; and are currently enrolled in another NIH study

      Design:

      Participants will be screened under another protocol.

      Participants will have a physical exam, blood tests, and medical history.

      Participants will breathe into a plastic device that measures lung strength.

      Participants may get a small plastic tube inserted in their arm.

      Participants who have not had an allergic reaction to food in the past 3 years will do 1 or
      more oral food challenge (OFCs) depending on their allergies.

      They will eat a little bit of the food they might be allergic to.

      They will be watched for a reaction. If they have one, they will know for sure they are
      allergic.

      They may keep eating bigger portions of the food until they either have a reaction or finish
      all the food.

      In some OFCs, participants will get a placebo food.

      OFCs will last a few hours or 2 days. Participants will repeat all tests at each OFC.

      Participation can last up to 12 months.

      ...
Allergy skin prick tests and measurement of food-specific immunoglobulin E (IgE) levels are
      common but not robust means to diagnose food allergy, so patients may be placed on overly
      restrictive food elimination diets as a result of false positive results. Such restrictions
      can lead to poor weight gain, malnutrition, and negative impact on quality of life. More than
      half of patients who are sensitized (ie, have a positive IgE test) to a particular food do
      not react to it during an oral food challenge, the gold standard for diagnosing food allergy.
      Development of food allergy does not always correlate to food-specific IgE levels. The care
      of these patients would be dramatically improved if decision points for food-specific or
      component IgEs could be identified that predict when an immediate hypersensitivity is
      present. This is especially an issue among patients with atopic dermatitis (AD), the most
      common chronic, relapsing inflammatory disorder of the skin affecting children. Patients with
      AD are more likely to develop other allergic conditions, including food allergy and
      sensitization. AD patients are also likely to have high levels of total serum IgE.

      In this study, participants aged 3-21 years (n = 175) with elevated total serum IgE levels
      and a history of AD will undergo open feedings and/or double-blind, placebo-controlled food
      challenges (DBPCFCs). Open feedings will be 1- or 2-step, depending on how often the
      participant regularly consumes the food at home. There are two DBPCFCs to milk: milk powder
      or (placebo) baked into a muffin, and straight milk powder or (placebo) mixed with a vehicle.
      The DBPCFC for peanut will be done with peanut flour or (placebo) mixed with a vehicle. Blood
      will be collected during the study for measurement of total and component IgEs as well as
      potential biomarkers of food sensitization vs. immediate hypersensitivity and reaction
      severity. From these data, we hope to identify diagnostic IgE threshold levels that will
      inform when oral food challenges are warranted in patients with elevated total serum IgE
      levels and AD, which is critically needed in the allergy field to facilitate the care of
      these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Allergy to milk and peanut status; allowing for estimation of IgE thresholds that determine a subgroup with at least 50% chance of tolerance in patients with elevated total serum IgE levels and history of AD.
time frame: Oral Food Challenge Visits
description: To estimate ROC curves for food specific and component IgE threshold levels in patients with elevated total serum IgE and a history of AD, to determine a subgroup with at least a 50% likelihood of tolerance to peanut and/or milk, via use of oral food challenges, and to estimate other diagnostic metrics (sensitivity and specificity) associated with this 50% risk threshold.
measure: Basophil and mast cell reactivity and other exploratory markers.
time frame: Oral Food Challenge Visitsv
description: To investigate the correlation between food-specific and/or component IgE values and other potential diagnostic tests for food allergy, including in vitro basophil and/or mast cell activation tests.
arm group label: Milk DBPCFC
arm group type: Experimental
description: There are two double blind placebo controlled food challenges. The first challenge is to baked milk. The following participants will undergo this DBPCFC: - All participants who eat baked milk less than once per month. - Participants who never eat baked milk or straight milk. On the first day of this challenge, participants will be randomized to either milk Baked milk or rice milk. Dry milk powder or corn starch. or placebo, and then will be challenged with the other food on the next day.
arm group label: One-Step Open Feeding
arm group type: Experimental
description: Participants who are consuming baked milk, straight milk, and/or peanut products at least once per week will do a one-step oral food challenge.
arm group label: Peanut DBPCFC
arm group type: Experimental
description: The DBPCFC for peanut allergy will be done with either peanut flour or a placebo (oat flour). The following participants will undergo this DBPCFC: - All participants who eat peanut less than once per month - Participants who never eat peanut On the first day of this challenge, participants will be randomized to either peanut or placebo, and then will be challenged with the other food on the next day.
arm group label: Two-Step Open Feeding
arm group type: Experimental
description: Participants who consume baked milk, straight milk, and/or peanut products less than once per week but at least once per month will do a two step open oral food challenge.
intervention type: Other
intervention name: Peanut powder and Oat flour
description: Peanut powder with 46% protein content is manufactured by PB2. Oat flour is manufactured by GF Harvest.
arm group label: One-Step Open Feeding
arm group label: Peanut DBPCFC
arm group label: Two-Step Open Feeding
intervention type: Other
intervention name: Peanut flour and Oat flour (placebo for peanut flour)
description: Peanut flour (12% light roast) with 50% protein content is manufactured by Byrd Mill. Oat flour is manufactured by GF Harvest.
arm group label: One-Step Open Feeding
arm group label: Peanut DBPCFC
arm group label: Two-Step Open Feeding
intervention type: Other
intervention name: Dry Milk Powder and Corn Starch (placebo for Milk powder)
description: Dry milk powder with 36% protein content is manufactured by Giant Food. Corn starch is Argo brand.
arm group label: Milk DBPCFC
arm group label: One-Step Open Feeding
arm group label: Two-Step Open Feeding
intervention type: Other
intervention name: Baked milk and Rice milk (placebo for Baked milk)
description: Baked milk will be in the form of a muffin provided by the NIH CC Nutrition Department. Rice milk is manufactured by Rice Dream brand.
arm group label: Milk DBPCFC
arm group label: One-Step Open Feeding
arm group label: Two-Step Open Feeding
criteria: 
gender: All
minimum age: 3 Years
maximum age: 21 Years
healthy volunteers: No
last name: Fernanda D Young, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
last name: Ellen Zektser, R.N.
phone: (301) 761-7565
email: ellen.zektser@nih.gov
last name: Fernanda D Young, M.D.
phone: (301) 761-6629
email: youngfd@nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2019-I-0053.html
description: NIH Clinical Center Detailed Web Page
citation: Fleischer DM, Bock SA, Spears GC, Wilson CG, Miyazawa NK, Gleason MC, Gyorkos EA, Murphy JR, Atkins D, Leung DY. Oral food challenges in children with a diagnosis of food allergy. J Pediatr. 2011 Apr;158(4):578-583.e1. doi: 10.1016/j.jpeds.2010.09.027. Epub 2010 Oct 28.
PMID: 21030035
citation: Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
PMID: 23195525
citation: Franxman TJ, Howe L, Teich E, Greenhawt MJ. Oral food challenge and food allergy quality of life in caregivers of children with food allergy. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):50-6. doi: 10.1016/j.jaip.2014.06.016. Epub 2014 Aug 29.
PMID: 25577618
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
mesh term: Peanut Hypersensitivity