Can a simple test predict peanut allergy reactions?

NCT ID NCT07279467

What the study statuses mean

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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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study aims to find biomarkers—signs in the body—that can tell if a child will have an allergic reaction to peanut during a feeding test. It will involve 500 children aged 1 to 17 who are suspected of having a peanut allergy. No treatment is given; the goal is to better understand how to predict reactions.

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.

Participants

About 500 people

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

Started

Aug 2026

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.

Who is studied

Approximately 500 participants with suspected peanut allergy, 12 months to 17 years of age

Ages

12 months to 17 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: 1. Parent or guardian must be able to understand and provide written informed consent and participant must be able to understand and provide assent (if applicable) 2. Are 12 months - 17 years of age during Screening. 3. Are sensitized to peanut, as demonstrated by one of the following: a. A participant-reported reaction to peanut (at any time) deemed by the investigator to be consistent with an IgE-mediated reaction and one of the following within the past 12 months i. Positive Skin Prick Test (SPT) to peanut (wheal diameter that is ≥ 3mm larger than saline control) ii. Positive peanut-specific IgE (sIgE; ≥ 0.10 kUA/L) determined by ImmunoCap b. An Ara h 2 sIgE ≥ 1.0 kUA/L, measured within the past 12 months 4. Are currently avoiding peanut Exclusion Criteria: 1. Are pregnant 2. Are currently receiving treatment or have received treatment within the prior 2 years for peanut allergy 3. Have a history of life-threatening anaphylaxis to peanut, defined as neurological compromise or requiring intubation 4. Have received treatment with dupilumab/Dupixent® within the prior 2 years, OR treatment with omalizumab/Xolair®, other biologics, or systemic immunomodulatory agents within the prior year 5. Inability to comply with the required aspects of the study protocol 6. Have past or current medical conditions or findings from the physical examination, not already listed, that, in the judgment of the site investigator, may pose additional risks related to participation in the study, interfere with the participant's ability to comply with study requirements, or impact the quality or interpretation of the study data 7. Have been treated with oral steroid or beta blockers within 14 days of the Oral Food Challenge (OFC) 8. Are unable to discontinue medications, as specified in the Protocol CoFAR-15 MOP, for the minimum wash-out periods prior to Skin Prick Test (SPT) or OFC 9. Have poorly controlled atopic dermatitis (AD) at Screening, per the PI's discretion 10. Have poorly controlled or severe asthma/wheezing at Screening, as defined as experiencing or including any of the following: 1. Meeting the Global Initiative for Asthma (GINA) criteria for uncontrolled asthma 2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing; 3. Prior intubation/mechanical ventilation for asthma/wheezing; 4. One hospitalization or ED visit for asthma/wheezing within six months of Screening; 5. Forced expiratory volume in one second (FEV1) \<80% of predicted or FEV1/forced vital capacity (FVC) \<75% of predicted, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry); 6. Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS based on the CoFAR Inhaled Corticosteroid Equivalency Tables MOP) 11. Refuse blood sample collection during Screening 12. The SPT performed during Screening is negative to peanut allergen without dilution (wheal diameter that is \< 3mm larger than saline control).

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Conditions

The condition(s) this trial relates to.

allergic disease food allergy Peanut Hypersensitivity

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

    10 sites. 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

  • Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital: Allergy and Asthma Program

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

    RECRUITING

    New York, New York, 10029, United States

  • Johns Hopkins Children's Center: Department of Allergy & Immunology

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lurie Children's Hospital of Chicago

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611-2927, United States

  • North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research

    RECRUITING

    Palo Alto, California, 94304, United States

  • The University of Michigan: Division of Allergy and Clinical Immunology

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

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