Recruiting
Phase 2

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT03835767

Conditions

Milk and/or Peanut Allergy

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

Interventions

Peanut powder and Oat flour

Peanut flour and Oat flour (placebo for peanut flour)

Dry Milk Powder and Corn Starch (placebo for Milk powder)

Baked milk and Rice milk (placebo for Baked milk)

Study Details

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 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.

...

Conditions

Milk and/or Peanut Allergy

Study ID

NCT03835767

Start date

Apr 19, 2019

Status verified date

Jun 22, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Milk DBPCFC

There are two double blind placebo controlled food challenges. The first challenge is to baked milk. The following participants will undergo this DBPCFC: - All participants who eat baked milk less than once per month. - Participants who never eat baked milk or straight milk. On the first day of this challenge, participants will be randomized to either milk Baked milk or rice milk. Dry milk powder or corn starch. or placebo, and then will be challenged with the other food on the next day.

experimental: One-Step Open Feeding

Participants who are consuming baked milk, straight milk, and/or peanut products at least once per week will do a one-step oral food challenge.

experimental: Peanut DBPCFC

The DBPCFC for peanut allergy will be done with either peanut flour or a placebo (oat flour). The following participants will undergo this DBPCFC: - All participants who eat peanut less than once per month - Participants who never eat peanut On the first day of this challenge, participants will be randomized to either peanut or placebo, and then will be challenged with the other food on the next day.

experimental: Two-Step Open Feeding

Participants who consume baked milk, straight milk, and/or peanut products less than once per week but at least once per month will do a two step open oral food challenge.

Interventions

Peanut powder and Oat flour

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)

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)

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)

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.

Primary outcome measure

  • Allergy to milk and peanut status; allowing for estimation of IgE thresholds that determine a subgroup with at least 50% chance of tolerance in patients with elevated total serum IgE levels and history of AD. [ Time Frame: Oral Food Challenge Visits ]

Central Contacts and Locations

Central contacts

Ellen Zektser, R.N.

(301) 761-7565ellen.zektser@nih.gov

Pamela A Frischmeyer-Guerrerio, M.D.

(301) 402-9782pamela.guerrerio@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Aug 26, 2026

Last verified

Jun 22, 2026

Keywords

  • Oral Food Challenge
  • Atopic Dermatitis
  • Milk
  • Peanut
  • Food Allergy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.