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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 21 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Oral Food Challenge;
Atopic Dermatitis;
Food Allergy

Recruitment Keyword(s)



milk and/or peanut allergy

Investigational Drug(s)


Investigational Device(s)



Other: Peanut powder and Oat flour
Other: Peanut flour and Oat flour (placebo for peanut flour)
Other: Dry Milk Powder and Corn Starch (placebo for Milk powder)
Other: Baked milk and Rice milk (placebo for Baked milk)

Supporting Site

NIH Clinical CenterNational Institute of Allergy and Infectious Diseases


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.


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


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


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.

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Individuals must meet all of the following criteria to be eligible for study participation:

1. Aged 3-21 years.

2. Currently enrolled on study 15-I-0162, Natural History and Genetics of Food Allergy and Related Conditions.

3. Has a total serum IgE level greater than or equal to 1000 kU/L at time of screening.

4. Has a history of AD based on self-report or physician assessment.

5. Willing to undergo an oral food challenge to both placebo and test food.

6. Willing to allow storage of blood samples for future use in medical research.

7. Willing to allow genetic testing to be conducted on blood samples.

8. Has a primary care physician or other physician who will manage all health conditions related or unrelated to the study objectives.

9.Be willing to discontinue omalizumab or dupilumab within 6 months of a food challenge,and antihistamines and oral steroids prior to a food challenge, as these drugs might interfere with the oral food challenge procedure. Use of topical steroids will be allowed

10. Able to provide informed consent.


Individuals meeting any of the following criteria will be excluded from study participation:

1. Pregnant.

2. Known genetic disorder that causes an elevation in total IgE level or one that could affect the severity of an anaphylactic response.

3. Known cardiac disease.

4. Current use of a beta-blocker.

5. Active eosinophilic gastrointestinal (GI) disorder including eosinophilic esophagitis, currently symptomatic, unless they are currently on treatment and have had a negative esophageal biopsy via endoscopy within at least the past 18 months, and/or unless the study food is already in the participants diets.

6. Any chronic medical condition requiring long-term use of oral steroids

7. Current or recent (within previous 6 months) use of omalizumab or dupilumab.

8. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.

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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.

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.

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.

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Principal Investigator

Referral Contact

For more information:

Fernanda D. Young, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 761-6629

Ellen Zektser, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6D44
10 Center Drive
Bethesda, Maryland 20892
(301) 761-7565

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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