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

Summary

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

• Milk and/or Peanut Allergy

Interventions

OTHER

Peanut powder and Oat flour

Peanut powder with 46% protein content is manufactured by PB2. Oat flour is manufactured by GF Harvest.

OTHER

Peanut flour and Oat flour (placebo for peanut flour)

Peanut flour (12% light roast) with 50% protein content is manufactured by Byrd Mill. Oat flour is manufactured by GF Harvest.

OTHER

Dry Milk Powder and Corn Starch (placebo for Milk powder)

Dry milk powder with 36% protein content is manufactured by Giant Food. Corn starch is Argo brand.

OTHER

Baked milk and Rice milk (placebo for Baked milk)

Baked milk will be in the form of a muffin provided by the NIH CC Nutrition Department. Rice milk is manufactured by Rice Dream brand.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Pamela A Guerrerio, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-19

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United States

Study Locations