Food Challenge at Home or in Medical Practice - the FoodCHOMP Study

Food allergies are highly prevalent and contribute to significant patient anxiety and healthcare utilisation. Many individuals carry food allergy labels without confirmation through diagnostic food challenge, resulting in unnecessary food avoidance. In-clinic food challenges are the current standard for confirming tolerance but are resource-intensive and often delayed. This study evaluates whether selected low-risk adults can safely complete a structured oral food challenge at home. This is a pilot, multi-centre, randomised controlled trial conducted at two tertiary allergy centres in Victoria, Australia (Austin Health and Royal Melbourne Hospital). Adults referred with a reported food allergy will undergo clinical assessment and skin prick testing. Those with negative skin testing (\<3mm wheal) to the implicated food and meeting other eligibility criteria will be randomised 1:1 to either: * Intervention: Home-based oral food challenge over five days, beginning with a single supervised dose in-clinic and followed by four incremental doses at home with daily clinical follow-up. * Control: Standard in-clinic oral food challenge using a protocol derived from PRACTALL and ASCIA guidelines. The primary outcome is the proportion of participants experiencing an immune-mediated adverse event during food challenge. Secondary outcomes include feasibility metrics (eligibility, recruitment, delivery), non-immune mediated adverse events, protocol adherence, quality of life (measured by FAQLQ-12), time to challenge, and real-world food reintroduction. The study will enrol 120 participants (60 per arm). Outcomes will inform the design of a future non-inferiority trial and may support integration of home challenges into routine practice for selected patients.