Evaluation of Hypoallergenicity of a New, Amino Acid–Based Formula

Abstract

The American Academy of Pediatrics (AAP) defined a formula as hypoallergenic if it ensures with 95% confidence that 90% of infants with confirmed cow’s milk allergy (CMA) will not react with defined symptoms under double-blind, placebo-controlled conditions. This study’s objective was to determine whether a new amino acid–based formula (AAF) meets the AAP hypoallergenicity criteria. Methods. Children with CMA were randomized to double-blind placebo-controlled food challenges (DBPCFC) with a new AAF and a commercial AAF in crossover fashion followed by an at-home open challenge with the new AAF. Allergic reactions were assessed using a scoring system. Results. Thirty-three subjects completed DBPCFCs with both formulas without acute allergic reactions. The lower bound 95% confidence interval for hypoallergenicity was 91.3%. No unusual stool patterns, allergic symptoms, or signs of intolerance were reported during the open challenge. Conclusion. The new AAF meets AAP hypoallergenicity criteria and can be recommended for the management of CMA.