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

  • End date
    Dec 31, 2027
  • participants needed
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 25 July 2022



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.


To improve the ways doctors test for food allergy in people with AD.


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


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.



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 correlate to food-specific IgE levels. The care of these patients would be dramatically improved if decision points for food-specific or component IgEs could be identified that predict when an immediate hypersensitivity is present. This is especially an issue among patients with atopic dermatitis (AD), the most common chronic, relapsing inflammatory disorder of the skin affecting children. Patients with AD are more likely to develop other allergic conditions, including food allergy and sensitization. AD patients are also likely to have high levels of total serum IgE.

In this study, participants aged 3-21 years (n = 175) with elevated total serum IgE levels and a history of AD will undergo open feedings and/or double-blind, placebo-controlled food challenges (DBPCFCs). Open feedings will be 1- or 2-step, depending on how often the participant regularly consumes the food at home. There are two DBPCFCs to milk: milk powder or (placebo) baked into a muffin, and straight milk powder or (placebo) mixed with a vehicle. The DBPCFC for peanut will be done with peanut flour or (placebo) mixed with a vehicle. Blood will be collected during the study for measurement of total and component IgEs as well as potential biomarkers of food sensitization vs. immediate hypersensitivity and reaction severity. From these data, we hope to identify diagnostic IgE threshold levels that will inform when oral food challenges are warranted in patients with elevated total serum IgE levels and AD, which is critically needed in the allergy field to facilitate the care of these patients.

Condition Milk and/or Peanut Allergy
Treatment Peanut flour and Oat flour (placebo for peanut flour), Dry Milk Powder and Corn Starch (placebo for Milk powder), Baked milk and Rice milk (placebo for Baked milk)
Clinical Study IdentifierNCT03835767
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on25 July 2022


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Inclusion Criteria

Individuals must meet all of the following criteria to be eligible for study
Aged 3-21 years
Currently enrolled on study 15-I-0162, Natural History and Genetics of Food Allergy and Related Conditions
Has a total serum IgE level greater than or equal to 1000 kU/L at time of screening
Has a history of AD based on self-report or physician assessment
Willing to undergo an oral food challenge to both placebo and test food
Willing to allow storage of blood samples for future use in medical research
Willing to allow genetic testing to be conducted on blood samples
Has a primary care physician or other physician who will manage all health conditions related or unrelated to the study objectives
Be willing to discontinue omalizumab or dupilumab within 6 months of a food challenge,and antihistamines and oral steroids prior to a food challenge, as these drugs might interfere with the oral food challenge procedure. Use of topical steroids will be allowed
Able to provide informed consent
Individuals meeting any of the following criteria will be excluded from study
Known genetic disorder that causes an elevation in total IgE level or one that could
Known cardiac disease
affect the severity of an anaphylactic response
Current use of a beta-blocker
Any chronic medical condition requiring long-term use of oral steroids
Active eosinophilic gastrointestinal (GI) disorder including eosinophilic esophagitis
Current or recent (within previous 6 months) use of omalizumab or dupilumab
currently symptomatic, unless they are currently on treatment and have had a negative
esophageal biopsy via endoscopy within at least the past 18 months, and/or unless the
study food is already in the participants diets
Any condition that, in the opinion of the investigator, contraindicates participation
in this study
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