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Study of Oral Food Challenge Biomarkers (SAFER)

NCT07279467 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

  • Allergy

Interventions

DRUG

Oral 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.

Sponsors & Collaborators

  • Consortia for Food Allergy Research (CoFAR)

    collaborator UNKNOWN

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Robert Wood, M.D. · Johns Hopkins Children's Center: Department of Allergy & Immunology

  • Supinda Bunyavanich, M.D., M.P.H., M.Phil. · Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

  • Charles Schuler, M.D. · The University of Michigan: Division of Allergy and Clinical Immunology

Eligibility

Min Age
12 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-10-01
Completion
2027-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279467 on ClinicalTrials.gov