Approximately 6%–10% of adults carry food allergy labels. Many such labels are unverified and may be incorrect, contributing to delays in appropriate care, significant dietary restriction, anxiety and unnecessary use of emergency medications. Oral food challenges (OFCs) are the gold standard for confirming or excluding food allergy, but the current model of clinic-based challenges often has long wait times and logistical barriers. This study aims to investigate the feasibility and safety of home-based OFCs compared with standard in-clinic challenges in adults with negative skin-prick testing.

Food Challenge at HOme or in Medical Practice is a pilot multicentre randomised controlled trial enrolling 120 adults with reported food allergy labels and negative skin prick testing to the implicated food. Participants will be randomised 1:1 to undergo an OFC either at home or in-clinic. The study is designed to generate feasibility and preliminary safety data for home-based OFC, measured by the proportion of participants experiencing immune-mediated adverse events (AEs), compared with clinic-based OFC. Feasibility metrics (screening to recruitment ratio, protocol completion), non-immune AEs, protocol adherence and quality of life assessed using the Food Allergy Quality of Life Questionnaire-12 at baseline prior to OFC and 6 months post OFC will also be collected. Statistical analysis will include descriptive statistics, with comparisons between arms using risk differences and relative risks with 95% CIs.

The trial has received ethics approval from the Austin Health Human Research Ethics Committee (HREC/111750/Austin-2024). Findings will be disseminated through peer-reviewed publications and scientific meetings. Data will be presented in aggregated, de-identified form.

NCT06916819.