Hypoallergenicity of a new whey-based, extensively hydrolyzed infant formula

The American Academy of Pediatrics (AAP) defines a formula as hypoallergenic if it ensures with 95% confidence that 90% of infants/children with confirmed cow’s milk allergy (CMA) will not react under double-blind, placebo-controlled conditions. We sought to determine whether a new whey-based, extensively hydrolysed formula (EHF) made with non-porcine enzymes meets the AAP hypoallergenicity criteria. Children with a clinical allergic reaction to cow’s milk (CM) within 6 months prior to enrollment, elevated serum sIgE levels, positive skin prick test and/or positive DBPCFC to CM were enrolled. Patients were randomized to double-blind, placebo-controlled food challenges (DBPCFC) in cross-over fashion with the new EHF (Test) and a commercially available EHF with proven hypoallergenicity (Control/Placebo). Challenge outcomes were assessed using a comprehensive scoring system. If DBPCFCs were tolerated, subjects participated in a one-week, open home challenge with the Test formula. 69 children (mean age 3.2 ± 2.2 years old) with confirmed CMA were enrolled and completed at least one DBPCFC. 66/67 (98.5%; lower 95% confidence interval 92.5%) tolerated the Test formula. The Test formula therefore meets the AAP hypoallergenicity criteria. 67/69 (97.1%) tolerated the Control formula (placebo). Average intake of Test formula during the open home challenge was 283 mL/day. All patients successfully completed the open challenge phase without clinically significant adverse reactions that would have warranted discontinuation of the challenge. The new whey-based EHF made with non-porcine enzymes meets the AAP criteria for hypoallergenicity and is suitable for the management of infants with CMA.