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New study aims to end false food allergy diagnoses in eczema patients

NCT ID NCT03835767

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study looks at 200 people aged 3–21 with eczema and high IgE levels who may have milk or peanut allergies. Researchers will use oral food challenges to find better ways to predict true allergies. The goal is to make allergy tests more accurate and reduce unnecessary food restrictions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to more accurate food allergy tests for people with eczema, reducing unnecessary food avoidance.
What could go wrong
This is an early-phase observational study, not a treatment trial. The findings may not apply to all patients or lead to immediate changes in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States