Eczema & High Allergy
Test Results Research Study

Researchers at the National Institutes of Health are studying how food allergies and eczema are connected in children and young adults. This study aims to improve how doctors diagnose food allergies, especially in patients who may be avoiding foods they can safely eat.

Fast Facts

History of Eczema & high allergy test results

Has a total serum IgE level > 900 kU/L at time of screening

3-21 Years Old

Participants will need to travel to Bethesda, MD for at least 1 visit.

Some visits may be done by Telehealth. Travel assistance may be available for those who qualify. 

Additional Information

Many children with eczema have high allergy test results, even if they are not truly allergic to certain foods. The purpose of the study is to identify better ways to diagnose food allergies in kids with a history of eczema and a high total allergy test. 

You or your child may be eligible for this study if the following criteria are met.

Inclusion Criteria:

  • Age 3-21 years old
  • Has a total serum IgE level > 900 kU/L at time of screening
  • Has a history of Atopic Dermatitis based on self-report or physician assessment
  • Willing to undergo an oral food challenge to both the placebo and test food
  • Has a primary care physician or other physician who will manage all health conditions related or unrelated to the study objectives

Exclusion Criteria:

  • Pregnant
  • A known genetic disorder that causes an elevation in total IgE level, or one that could affect the severity of an anaphylactic response
  • Active eosinophilic gastrointestinal (GI) disorder, including eosinophilic esophagitis, currently symptomatic, unless the participant is currently on treatment and has 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

Overall Duration

The length of the study can vary for each participant. It may involve one or more visits over time, depending on medical history and test results.

In-Lab Activities

Participants will visit the NIH Clinical Center in Bethesda, Maryland.

During study visits, participants may:

  • Meet with doctors and research staff to review medical history
  • Have a physical exam and eczema evaluation
  • Provide a blood sample for allergy testing
  • Complete allergy skin testing
  • Take part in supervised food challenges, where small amounts of food or a placebo are given in a safe setting

Food challenges are closely monitored by medical staff to watch for any reactions.

Participants or caregivers may be asked to:

  • Share information about diet and symptoms
  • Follow any instructions given by the study team before or after visits

 

Additional Details

Participants must have a regular doctor who manages their health outside of the study. Children under 18 must have a parent or caregiver attend study visits with them. Participants will need to travel to Bethesda, Maryland for at least one visit.

Compensation is available and varies depending on participation.

Participants may also receive:

  • Nutrition evaluation and counseling
  • Food allergy education and testing
  • Access to treatments and prescriptions if needed, including EpiPens

There is no cost for you to participate in our research study.