Prospective Study to Identify Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in Patients With Elevated Total Serum IgE Levels and Atopic Dermatitis
National Institute of Allergy and Infectious Diseases (NIAID)
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. ...
Description
Allergy skin prick tests and measurement of food-specific immunoglobulin E (IgE) levels are common but not robust means to diagnose food allergy, so patients may be placed on overly restrictive food elimination diets as a result of false-positive results. Such restrictions can lead to poor weight gain, malnutrition, and negative impact on quality of life. More than half of patients who are sensitized (ie, have a positive IgE test) to a particular food do not react to it during an oral food challenge, the gold standard for diagnosing food allergy. Development of food allergy does not always cor…
Eligibility
- Age range
- 3–21 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: Individuals must meet all of the following criteria to be eligible for study participation: 1. Aged 3-21 years. 2. Currently enrolled on study 15-I-0162, "Natural History and Genetics of Food Allergy and Related Conditions." 3. Has a total serum IgE level \>= 900 kU/L at time of screening. 4. Has a history of AD based on self-report or physician assessment. 5. Willing to undergo an oral food challenge to both placebo and test food. 6. Willing to allow storage of blood samples for future use in medical research. 7. Willing to allow genetic testing to be conducted on bloo…
Interventions
- OtherPeanut powder and Oat flour
Peanut powder with 46% protein content is manufactured by PB2. Oat flour is manufactured by GF Harvest.
- OtherPeanut 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.
- OtherDry 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.
- OtherBaked 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.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland