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

Conditions

• Milk and/or Peanut Allergy

Eligibility Criteria

Sex

ALL

Age

3 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Peanut powder and Oat flour — OTHER
  Peanut powder with 46% protein content is manufactured by PB2. Oat flour is manufactured by GF Harvest.
• Peanut flour and Oat flour (placebo for peanut flour) — OTHER
  Peanut flour (12% light roast) with 50% protein content is manufactured by Byrd Mill. Oat flour is manufactured by GF Harvest.
• Dry Milk Powder and Corn Starch (placebo for Milk powder) — OTHER
  Dry milk powder with 36% protein content is manufactured by Giant Food. Corn starch is Argo brand.
• Baked milk and Rice milk (placebo for Baked milk) — OTHER
  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.

Study Details

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. ...

Key Dates

Start date

Apr 19, 2019

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Milk DBPCFC
  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.
• Experimental: One-Step Open Feeding
  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.
• Experimental: Peanut DBPCFC
  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.
• Experimental: Two-Step Open Feeding
  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.

Primary Outcome Measure

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. [ Time Frame: Oral Food Challenge Visits ]

Central Contacts

• Ellen Zektser, R.N.
  (301) 761-7565
  [email protected]
• Pamela A Guerrerio, M.D.
  (301) 402-9782
  [email protected]

Locations (1)

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