Study of Oral Food Challenge Biomarkers (SAFER)
ConditionAllergy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-17
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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 criteria
Qualifiers
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)
Are 12 months - 17 years of age during Screening.
Are currently avoiding peanut
Disqualifiers
Are pregnant
Are currently receiving treatment or have received treatment within the prior 2 years for peanut allergy
Have a history of life-threatening anaphylaxis to peanut, defined as neurological compromise or requiring intubation
Have received treatment with dupilumab/Dupixent® within the prior 2 years, OR treatment with omalizumab/Xolair®, other biologics, or systemic immunomodulatory agents within the prior year
Trial design
Treatments tested in this trial
- Oral Food Challenge (OFC): Peanut Protein
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Consortia for Food Allergy Research (CoFAR)
Collaborator
Rho Federal Systems Division, Inc.
Collaborator
Source ClinicalTrials.gov