RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) • ClinicalTrials.gov ID: NCT03835767

Registry updated: 2026-08-26

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Description

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 not always accurate in people with AD. Researchers want to study if people are truly allergic to milk and/or peanuts. Objectives: To improve the ways doctors test for food allergy in people with AD. Eligibility: 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 Design: 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. ...

Interventions

Peanut powder and Oat flour (Other)
Peanut powder with 46% protein content is manufactured by PB2. Oat flour is manufactured by GF Harvest.
Peanut flour and Oat flour (placebo for peanut flour) (Other)
Peanut flour (12% light roast) with 50% protein content is manufactured by Byrd Mill. Oat flour is manufactured by GF Harvest.
Dry Milk Powder and Corn Starch (placebo for Milk powder) (Other)
Dry milk powder with 36% protein content is manufactured by Giant Food. Corn starch is Argo brand.
Baked milk and Rice milk (placebo for Baked milk) (Other)
Baked milk will be in the form of a muffin provided by the NIH CC Nutrition Department. Rice milk is manufactured by Rice Dream brand.

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.

Conditions

Milk and/or Peanut Allergy

Locations

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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