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.


CONCLUSIONS
. The new AAF meets AAP hypoallergenicity criteria and can be recommended for the management of CMA.
Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Anna
A
Nowak-Węgrzyn
Nestlé Nutrition, Florham Park, NJ, USA.
Laura A
LA
Czerkies
Clinipace Worldwide, Morrisville, NC, USA.
Barbara
B
Collins
Nestlé Nutrition, Florham Park, NJ, USA Johns Hopkins University, Baltimore, MD jose.saavedra@nestle.com.
José M
JM
Saavedra
D000596:Amino Acids / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000379:methods*; D008297:Male; D016269:Milk Hypersensitivity / Q000178:diet therapy*
D000596:Amino Acids
cow’s milk allergy; hypoallergenic; infant formula