Nowak-Wegrzyn A , Czerkies LA , Collins B , Saavedra JM. - 46115 N - Clin Pediatr (Phila) 2015 ; in press.
Evaluation of Hypoallergenicity of a New, Amino Acid-Based Formula
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.