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…
Eligibility
- Age range
- 1–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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) 2. Are 12 months - 17 years of age during Screening. 3. Are sensitized to peanut, as demonstrated by one of the following: a. A participant-reported reaction to peanut (at any time) deemed by the investigator to be consistent with an IgE-mediated reaction and one of the following within the past 12 months i. Positive Skin Prick Test (SPT) to peanut (wheal diameter that is ≥ 3mm larger than saline control…
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 & ImmunologyLittle Rock, Arkansas
- Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma ResearchPalo Alto, California
- Northwestern University Feinberg School of Medicine: Allergy DivisionChicago, Illinois
- Johns Hopkins Children's Center: Department of Allergy & ImmunologyBaltimore, Maryland
- Boston Children's Hospital: Allergy and Asthma ProgramBoston, Massachusetts
- The University of Michigan: Division of Allergy and Clinical ImmunologyDetroit, Michigan