Can a simple test predict peanut allergy reactions?
NCT ID NCT07279467
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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12 months to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
NOT_YET_RECRUITINGLittle Rock, Arkansas, 72202, United States
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Boston Children's Hospital: Allergy and Asthma Program
NOT_YET_RECRUITINGBoston, Massachusetts, 02115, United States
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Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology
NOT_YET_RECRUITINGCincinnati, Ohio, 45229, United States
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Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
RECRUITINGNew York, New York, 10029, United States
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Johns Hopkins Children's Center: Department of Allergy & Immunology
RECRUITINGBaltimore, Maryland, 21287, United States
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Lurie Children's Hospital of Chicago
NOT_YET_RECRUITINGChicago, Illinois, 60611-2927, United States
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North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
NOT_YET_RECRUITINGChapel Hill, North Carolina, 27599, United States
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Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research
RECRUITINGPalo Alto, California, 94304, United States
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The University of Michigan: Division of Allergy and Clinical Immunology
NOT_YET_RECRUITINGAnn Arbor, Michigan, 48109, United States
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Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
NOT_YET_RECRUITINGNashville, Tennessee, 37232, United States
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