Not Yet RecruitingNot Applicable

Study of Oral Food Challenge Biomarkers (SAFER)

United States500 participantsStarted 2026-04

Plain-language summary

This is a multi-center, mechanistic study. It is designed to learn more about signs in the body, called biomarkers, that might show if someone will have a reaction to peanut during a feeding test. The trial will enroll children ages 12 months to17 years old who are suspected of having an allergy to peanut. The primary objective is to identify a biomarker (or a combination of biomarkers) that will predict oral food challenge (OFC) (feeding test) results for participants with suspected peanut allergy.

Who can participate

Age range12 Months – 17 Years

SexALL

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Inclusion criteria

✓. 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)
✓. Are 12 months - 17 years of age during Screening.
✓. Are sensitized to peanut, as demonstrated by one of the following:
✓. Are currently avoiding peanut

Exclusion criteria

✕. Are pregnant
✕. Are currently receiving treatment or have received treatment within the prior 2 years for peanut allergy
✕. Have a history of life-threatening anaphylaxis to peanut, defined as neurological compromise or requiring intubation
✕. 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
✕. Inability to comply with the required aspects of the study protocol
✕. 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
✕. Have been treated with oral steroid or beta blockers within 14 days of the Oral Food Challenge (OFC)

What they're measuring

Cumulative Reactive Dose (CRD) Threshold

Timeframe: OFC Visit on Day 1

Binary Reaction Status (reactor/non-reactor) to the oral food challenge (OFC)

Timeframe: OFC Visit on Day 1

Trial details

NCT IDNCT07279467

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2027-10-01

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