Evaluation of an Extensively Hydrolyzed Casein‐Whey Protein Formula in Immediate Cow's Milk Protein Hypersensitivity

ABSTRACT Background: Hydrolysate formulas are safe for most infants who are allergic to cow's milk. The purpose of this study was to assess the clinical tolerance and safety of an extensively hydrolyzed casein‐whey protein formula in a homogeneous group of patients with immediate cow's milk hypersensitivity. Methods: The study population consisted of 33 infants in whom immediate cow's milk protein allergy had been diagnosed by clinical data, evidence of specific immunoglobulin E antibodies, and positive results in a controlled challenge test with cow's milk proteins. Results: The hydrolysate was well tolerated in 31 of the 33 patients, which represented a 94% effectiveness. Using 95% confidence intervals generated for a binomial outcome (reaction‐no reaction), the casein‐whey protein formula is tolerated by 84.4% to 99% of infants with immediate immunoglobulin‐E‐mediated cow's milk protein allergy. These figures are in the range of values recommended for this type of product. Conclusions: This extensively hydrolyzed casein‐whey protein formula is generally safe to feed children with immediate hypersensitivity to cow's milk. However, it is advisable that the first intakes be given under direct medical supervision, in that the occurrence of adverse reactions in highly sensitive infants cannot be unequivocally excluded.