Study of Oral Food Challenge Biomarkers (SAFER)
Start Date
8/20/2026
Completion Date
12/1/2027
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.
Detailed 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) and 100 non-reactors. Recruitment will aim to achieve approximate balance across three age groups: 12-47 months, 4-11 years, and 12-17 years. An initial screening visit will be conducted to evaluate eligibility and collect the biomarkers prior to the oral food challenge. The food challenge can take place on the same day as screening or within 4 weeks of the screening visit. During participation, clinical assessments will be conducted, questionnaires completed, and biological samples collected from the participant before, during, and after the challenge. After the food challenge and the safety monitoring period is completed, the participant will have completed participation in the study.
Eligibility Criteria
Age Range: No minimum to 17 years
Interventions
Oral Food Challenge (OFC): Peanut Protein
Conditions
Locations
Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
Little Rock, Arkansas 72202
United States
Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research
Palo Alto, California 94304
United States
Lurie Children's Hospital of Chicago
Chicago, Illinois 60611-2927
United States
Johns Hopkins Children's Center: Department of Allergy & Immunology
Baltimore, Maryland 21287
United States
Boston Children's Hospital: Allergy and Asthma Program
Boston, Massachusetts 02115
United States
The University of Michigan: Division of Allergy and Clinical Immunology
Ann Arbor, Michigan 48109
United States
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
New York, New York 10029
United States
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina 27599
United States
Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology
Cincinnati, Ohio 45229
United States
Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
Nashville, Tennessee 37232
United States