RecruitingNCT07279467

Study of Oral Food Challenge Biomarkers (SAFER)

Study of Oral Food Challenge Biomarkers (CoFAR-15)


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

500 participants

Start Date

Aug 20, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 12 MonthsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oral Food Challenge (OFC): Peanut Protein for people with allergy. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral Food Challenge (OFC): Peanut Protein

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.


Locations(10)

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

Little Rock, Arkansas, United States

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

Palo Alto, California, United States

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

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

Baltimore, Maryland, United States

Boston Children's Hospital: Allergy and Asthma Program

Boston, Massachusetts, United States

The University of Michigan: Division of Allergy and Clinical Immunology

Ann Arbor, Michigan, United States

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

New York, New York, United States

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

Chapel Hill, North Carolina, United States

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

Cincinnati, Ohio, United States

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

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT07279467


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