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

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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 with AD and high total IgE levels are
truly allergic to milk and/or peanuts with the aim of improving the ways doctors test for food allergy
in people with AD.

What Does the Study Involve?

In this study, participants aged 3-21 years (n = 175) with elevated total serum IgE levels and a history
of AD will receive a comprehensive allergy evaluation including food allergy testing, a plan and
medications to treat their AD, and a nutritional assessment and counseling sessions with a dietitian.
Additionally, participants will undergo open feedings and/or double-blind, placebo-controlled food
challenges (DBPCFCs) to peanuts and/or milk. The challenges will conclusively determine if the
participant is truly allergic to milk and/or peanuts and whether they can safely reintroduce the food(s)
into their diet or if they need to continue avoiding the food(s). The challenges are done in an inpatient
unit at the NIH Clinical Center with staff who have expertise in performing food challenges.

Who Can Participate?

People ages 3-21 who have had AD and have a high total IgE level (an allergic antibody)

Where Is It Taking Place?

National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892

Is There a Cost?

Participants will not be charged for any service offered, and medical insurance is not required.

Is Compensation Provided?

Participants will be compensated for their time and travel/accommodation expenses.

Number of Visits Required

2-3 visits

Steps To Participate

Contact us at 301-761-7565 or at niaidfars2@nih.gov

Sponsor

Thermo Fisher

Collaborators

Pamela A Guerrerio, M.D.

Visit ClinicalTrials.gov for details.

Contact Information

 Contact us at 301-761-7565 or at niaidfars2@nih.gov

Participating in Research

Watch a series of short informational videos about participating in clinical trials. These videos are intended to help potential participants understand how research works, what questions they should consider asking, and things to think about when deciding whether or not to participate in a study.

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