The dilemma of open or double‐blind food challenges in diagnosing food allergy in children: Design of the ALDORADO trial

BACKGROUND: It is of major importance to diagnose food allergy accurately. Current guidelines support the use of oral food challenges to do so. The double‐blind placebo‐controlled food challenge (DBPCFC) has been regarded as the ‘gold standard’ for decades. However, DBPCFCs are costly, and time‐ and resource‐intensive procedures. Structural implementation of less demanding open food challenges will only find support if research demonstrates that their outcome is comparable to DBPCFC, yet this has been proven difficult to investigate. METHODS: We performed a literature review to investigate the diagnostic accuracy of oral food challenges and interviewed 19 parents of children with proven or suspected food allergy about the design of a trial to study this. RESULTS: An overview of the dilemma of diagnosing food allergy using oral food challenges, and the methodological issues and parents’ opinions to study this. No comparative studies have been performed using the latest guidelines on oral food challenges. CONCLUSIONS: There is an urgent need to investigate the diagnostic accuracy of different oral food challenge protocols. We present the rationale and design of the ALDORADO trial (ALlergy Diagnosed by Open oR DOuble‐blind food challenge) that has been set up to investigate whether the outcome of the open food challenge is comparable to DBPCFC.