Study of Oral Food Challenge Biomarkers (SAFER)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07279467
Status
Not Yet Recruiting

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Conditions

  • Allergy

Eligibility Criteria

Sex
ALL
Age
12 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral Food Challenge (OFC): Peanut Protein — DRUG
    Peanut protein flour will be used in the OFC procedure. The maximum cumulative dose of peanut protein for completion of the oral food challenge (OFC) is 6043 mg. Participants aged 3 years or younger are not required to receive the final 2000 mg dose to complete the OFC; however, it may be administered at the discretion of the investigator if considered clinically relevant and safe.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Dec 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Oral Food Challenge Cohort
    Approximately 500 children and adolescent participants between the ages of 1-17 years who are suspected of having an allergy to peanut will be asked to complete a Peanut Oral Food Challenge. An individual's participation in this study will consist of screening for eligibility and an oral food challenge visit, which may occur on the same day or up to 28 days apart.

Primary Outcome Measure

Cumulative Reactive Dose (CRD) Threshold [ Time Frame: OFC Visit on Day 1 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & ImmunologyLittle RockArkansas72202-
Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma ResearchPalo AltoCalifornia94304-
Northwestern University Feinberg School of Medicine: Allergy DivisionChicagoIllinois60611-2927-
Johns Hopkins Children's Center: Department of Allergy & ImmunologyBaltimoreMaryland21287-0010-
Boston Children's Hospital: Allergy and Asthma ProgramBostonMassachusetts02115-
The University of Michigan: Division of Allergy and Clinical ImmunologyDetroitMichigan48201-
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & ImmunologyNew YorkNew York10029-
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and RheumatologyChapel HillNorth Carolina27599-
Cincinnati Children's Hospital Medical Center: Division of Allergy and ImmunologyCincinnatiOhio45229-
Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary MedicineNashvilleTennessee37232-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology· Little Rock, ARStanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research· Palo Alto, CANorthwestern University Feinberg School of Medicine: Allergy Division· Chicago, ILJohns Hopkins Children's Center: Department of Allergy & Immunology· Baltimore, MDBoston Children's Hospital: Allergy and Asthma Program· Boston, MAThe University of Michigan: Division of Allergy and Clinical Immunology· Detroit, MI

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