Status:
RECRUITING
Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
National Institutes of Health Clinical Center (CC)
Conditions:
Milk and/or Peanut Allergy
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
Brief 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 no...
Detailed 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 e...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
April 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03835767
Start Date
April 19 2019
End Date
December 31 2027
Last Update
August 24 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892