Evaluation of an extensively hydrolysed casein formula (Damira 2000®) in children with allergy to cow's milk proteins

ABSTRACT

Objective: To assess the allergenic capacity of a new extensively hydrolysed case in formula (Damira 2000®) in vivo in children with allergy to cow's milk, and to conduct an immunochemical evaluation of the product. Patients and methods: The study comprised 67 children (1 month–7 years) with allergy to cow's milk proteins (ACMP). Skin testing was made with whole milk, milk formula for infants, the study hydrolysate and the milk fractions (alpha-lactoalbumin, beta-lactoglobulin and casein). Specific IgE against these allergens, and oral provocation test were also performed. Immunochemical evaluation of the product was carried out with gel filtration chromatography, 4–15% acrylamide gradient gel electrophoresis, specific IgE quantification versus the casein hydrolysate and a study of its allergenic potency. Results: The hydrolysate was tolerated by 66 of the 67 patients (98.5%) with ACMP. Biochemical analysis of the product confirmed the absence of traces of whole milk proteins. Specific IgE against the hydrolysate proved negative in all cases, and it was unable to inhibit FEIA even at concentrations 10 times greater than those used in the whole milk inhibition control. Likewise, no immunoblotting inhibition was recorded. Conclusions: The new extensively hydrolysed casein product is safe and well tolerated by most children with ACMP. However, as with other extensive hydrolysates, some highly sensitised patients may present clinical manifestations. Controlled tolerance testing is therefore advised, under specialised medical supervision