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

Inclusion Criteria22

• Individuals must meet all of the following criteria to be eligible for study participation:
• 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 >= 900 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.
• EXCLUSION CRITIERIA:
• Individuals meeting any of the following criteria will be excluded from study participation:
• Pregnant.
• Known genetic disorder that causes an elevation in total IgE level or one that could affect the severity of an anaphylactic response.
• Known cardiac disease.
• Current use of a beta-blocker.
• Active eosinophilic gastrointestinal (GI) disorder including eosinophilic esophagitis, 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 chronic medical condition requiring long-term use of oral steroids.
• Current or recent (within previous 6 months) use of omalizumab or dupilumab.
• Any condition that, in the opinion of the investigator, contraindicates participation in this study.
• Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.