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IgE Threshold Testing for Food Allergy

Phase 2

Recruiting

Led By Fernanda D Young, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 3-21 years.

Be younger than 65 years old

Must not have

Known cardiac disease.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up oral food challenge visits

Summary

This trial is testing whether people with atopic dermatitis are truly allergic to milk and/or peanuts.

Who is the study for?

This trial is for children and young adults aged 3-21 with atopic dermatitis (eczema) who may have milk or peanut allergies, a high total IgE level, and are part of another NIH study. They must be willing to stop certain allergy medications before food challenges.

What is being tested?

The trial tests if participants with eczema are truly allergic to milk or peanuts by giving them increasing amounts of these foods or placebos in controlled settings. The goal is to improve food allergy testing methods.

What are the potential side effects?

Potential side effects include allergic reactions during the oral food challenge, ranging from mild symptoms like itching to more severe reactions that could require medical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known heart condition.

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I am on long-term oral steroids for a chronic condition.

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I am currently taking a beta-blocker medication.

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I have a genetic condition that increases my IgE levels or affects severe allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ oral food challenge visitsv

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~oral food challenge visitsv

This trial's timeline: 3 weeks for screening, Varies for treatment, and oral food challenge visitsv for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Basophil and mast cell reactivity and other exploratory markers.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Two-Step Open FeedingExperimental Treatment4 Interventions

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.

Group II: Peanut DBPCFCExperimental Treatment2 Interventions

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.

Group III: One-Step Open FeedingExperimental Treatment4 Interventions

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.

Group IV: Milk DBPCFCExperimental Treatment2 Interventions

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.

0 / 5Eligibility criteria met