A Novel Double-Blind, Placebo-Controlled Food Challenge Matrix for Milk and Raw Egg.

Background: The double-blind, placebo-controlled food challenge (DBPCFC) is still considered to be the gold standard in food allergy diagnosis. This test is however not common practice in routine due to several practical limitations, especially for non-IgE-mediated food allergy with its typical delayed food allergic reactions.

Objective: The aim of this study was to develop and evaluate DBPCFC matrices for the diagnosis of milk and egg allergies which can be applied at home for the diagnosis of delayed food allergic reactions. The main focus was the blinding of milk and raw egg and the development of matrices which can be prepared and consumed conveniently at home with a sufficiently long shelf life (+/- 6 months or longer).

Methods: A sensory test evaluated the blinding of the egg and milk in the matrices. The microbiological analysis confirmed the safety and stability of the developed matrices. To assess the applicability of the matrices, a pilot DBPCFC study for milk including 7 patients was conducted.

Results: Sensory tests confirmed that the masking of the allergenic ingredients was sufficient. Microbial safety and stability of the matrices were confirmed up to 6 months of storage at ambient temperatures in the dark. The DBPCFC for milk showed different outcomes and proved its applicability for use at home.

Conclusion: A novel stable DBPCFC matrix for milk and raw egg has been developed that allows convenient use at the patients' home.