Actively Recruiting
Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-20
200
Participants Needed
1
Research Sites
454 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
N
National Institutes of Health Clinical Center (CC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. ...
CONDITIONS
Official Title
Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 3-21 years
- Currently enrolled in study 15-I-0162, "Natural History and Genetics of Food Allergy and Related Conditions"
- Has total serum IgE level of 900 kU/L or higher at screening
- Has a history of atopic dermatitis based on self-report or physician assessment
- Willing to undergo oral food challenges to both placebo and test foods
- Willing to allow storage of blood samples for future medical research
- Willing to allow genetic testing on blood samples
- Has a primary care physician or other physician to manage health conditions
- Willing to stop omalizumab or dupilumab within 6 months before a food challenge
- Willing to stop antihistamines and oral steroids before a food challenge; topical steroids allowed
- Able to provide informed consent
You will not qualify if you...
- Pregnant
- Known genetic disorder causing elevated total IgE or affecting anaphylaxis severity
- Known cardiac disease
- Current use of beta-blockers
- Active eosinophilic gastrointestinal disorder currently symptomatic unless treated and biopsy negative within past 18 months, or study food already in diet
- Chronic medical condition requiring long-term oral steroids
- Current or recent (within 6 months) use of omalizumab or dupilumab
- Any condition that contraindicates study participation according to investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
E
Ellen Zektser, R.N.
CONTACT
P
Pamela A Guerrerio, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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