Identifying food allergies in children with atopic dermatitis

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

This study is trying to find out if certain food allergy tests can help kids with atopic dermatitis and high IgE levels better identify allergies to milk and peanuts.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 3 Years to 21 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: omalizumab, dupilumab
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03835767 on ClinicalTrials.gov

What this trial studies

This study aims to improve the accuracy of food allergy testing in children aged 3 to 21 years who have atopic dermatitis and elevated total serum IgE levels. Participants will undergo oral food challenges to assess their reactions to milk and peanuts, which are common allergens. The study will involve physical exams, blood tests, and lung function assessments to gather comprehensive data on the participants' allergic responses. By identifying specific IgE thresholds that predict food allergies, the research seeks to reduce unnecessary dietary restrictions and improve patient quality of life.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 3 to 21 years with a history of atopic dermatitis and elevated total serum IgE levels.

Not a fit: Patients who do not have atopic dermatitis or whose total serum IgE levels are below the required threshold may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate food allergy diagnoses, reducing unnecessary dietary restrictions and improving the quality of life for affected patients.

How similar studies have performed: Other studies have shown success in using oral food challenges to better diagnose food allergies, making this approach a promising advancement in the field.

Eligibility criteria

* 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 blood samples.
8. Has a primary care physician or other physician who will manage all health conditions related or unrelated to the study objectives.
9. 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
10. Able to provide informed consent.

EXCLUSION CRITIERIA:

Individuals meeting any of the following criteria will be excluded from study participation:

1. Pregnant.
2. Known genetic disorder that causes an elevation in total IgE level or one that could affect the severity of an anaphylactic response.
3. Known cardiac disease.
4. Current use of a beta-blocker.
5. 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.
6. Any chronic medical condition requiring long-term use of oral steroids.
7. Current or recent (within previous 6 months) use of omalizumab or dupilumab.
8. 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Pamela A Guerrerio, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Ellen Zektser, R.N.

Conditions Milk and/or Peanut Allergy; Oral Food Challenge; Atopic Dermatitis; Milk; Peanut; Food Allergy