Study of Oral Food Challenge Biomarkers (CoFAR-15)
National Institute of Allergy and Infectious Diseases (NIAID)
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.
Description
The SAFER study is a multi-center, mechanistic study designed to identify biomarkers that can predict the outcome of a participant's reactions to a peanut oral food challenge. Participants aged 12 months to 17 years with suspected peanut allergy will complete an oral food challenge to peanut. The accrual goal of the study is to reach a minimum of 500 participants who complete the oral food challenge and provide blood needed to assess biomarkers. Recruitment may continue beyond 500 to ensure there are at least 350 reactors (i.e., participants who experience dose-limiting symptoms during the OFC…