Study of Oral Food Challenge Biomarkers (SAFER) for Peanut Allergy
This study, called SAFER, is looking for children aged 12 months to 17 years who are suspected of having a peanut allergy. The goal is to find signs in the body, called biomarkers, that can predict if someone will react to peanut during a feeding test. You would participate in an oral food challenge (OFC) where you are given small, increasing amounts of peanut protein flour to see if a reaction occurs. Researchers will collect blood samples and other information before, during, and after the challenge. The study aims to enroll at least 500 participants to help identify these important biomarkers.
- Study design
- This is an observational study aiming to enroll at least 500 participants. It is designed to understand how the body responds to peanut protein.
- What's involved
- You would have a screening visit, participate in an oral food challenge with peanut protein, and have clinical assessments, questionnaires, and biological sample collections before, during, and after the challenge.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the food challenge and a safety monitoring period, your participation in the study will be complete.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Oral Food Challenge Biomarkers (SAFER)
At a glance
Conditions
Where it's being run
10 sites across 10 statesStudy leadership
- Robert Wood, M.D. · STUDY_CHAIR · Johns Hopkins Children's Center: Department of Allergy & Immunology
- Supinda Bunyavanich, M.D., M.P.H., M.Phil. · STUDY_CHAIR · Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
- Charles Schuler, M.D. · STUDY_CHAIR · The University of Michigan: Division of Allergy and Clinical Immunology
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Cumulative Reactive Dose (CRD) ThresholdOFC Visit on Day 1
The cumulative quantity of peanut protein consumed during an oral food challenge at which dose-limiting symptoms occur, categorized as: 3-143 mg (low threshold); 443-1043 mg (medium threshold); 2043-highest cumulative, age-dependent dose (high threshold); or no reaction. The maximum cumulative dose of peanut protein for completion of the oral food challenge (OFC) is 4043 mg for participants aged 1 to 3 years and 6043 mg for participants aged 4 to 17 years. Participants ≤3 years are not required to receive the final 2000mg dose to complete the OFC, however, it may be administered at the discretion of the investigator if considered clinically relevant and safe.
- Binary Reaction Status (reactor/non-reactor) to the oral food challenge (OFC)OFC Visit on Day 1
A Reactor is any participant who experiences dose-limiting symptoms at or prior to the highest cumulative, age-dependent OFC dose. A Non-reactor is any participant who does not experience dose-limiting symptoms during an OFC that is completed to the age-specific highest dose.