Food Allergy Testing for Milk and Peanut in People with Eczema

This study is looking for better ways to test for milk and/or peanut allergies in people aged 3 to 21 who have atopic dermatitis (eczema) and high total IgE levels (an allergic antibody). Current tests for food allergies can sometimes be inaccurate, leading to unnecessary dietary restrictions. Researchers will use different forms of milk and peanut, including Peanut powder, Peanut flour, Dry Milk Powder, and Baked milk, along with placebos like Oat flour, Corn Starch, and Rice milk, to determine if someone is truly allergic. The goal is to find specific IgE levels that can accurately predict a food allergy, helping doctors make better diagnoses and avoid unnecessary food restrictions. This study is for people already enrolled in another NIH study (15-I-0162).

Study design
This is an interventional study planning to enroll 200 participants. It uses different food products and placebos to test for allergies.
What's involved
Participants will have a physical exam, blood tests, and medical history taken. They will also undergo open feedings and/or double-blind, placebo-controlled food challenges.
Compensation
Not stated in the trial record.
Follow-up
Allergy to milk and peanut status will be measured at Oral Food Challenge Visits.

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NCT03835767

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

Recruiting
PHASE2Ages 3–21InterventionalDiagnostic
National Institute of Allergy and Infectious Diseases (NIAID)
~200 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Peanut powder and Oat flourPeanut flour and Oat flour (placebo for peanut flour)Dry Milk Powder and Corn Starch (placebo for Milk powder)Baked milk and Rice milk (placebo for Baked milk)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Oral Food Challenge Visits
Milk and/or Peanut Allergy
1 sites across 1 states
Maryland1
  • Pamela A Frischmeyer-Guerrerio, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

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  • 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.Oral Food Challenge Visits

    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.