Hypoallergenicity of a new extensively hydrolyzed 100% whey-based formula containing probiotics

RATIONALE: The American Academy of Pediatrics (AAP) defined 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 100% whey protein extensively hydrolyzed formula (EHF) containing B. lactis CNCM I-3446, meets AAP hypoallergenicity criteria. METHODS: Children with CMA were randomized to double-blind placebo-controlled food challenges (DBPCFC) with a new EHF (Test) and a commercial EHF (Control) in crossover fashion. CMA was confirmed within 6 months prior to enrollment by elevated serum cow's milk (CM)-IgE levels, positive skin prick test to CM extract, or positive CM oral challenge. Allergic reactions were assessed using a comprehensive scoring system. If both DBPCFCs were tolerated, subjects participated in an at-home week-long Test open challenge. RESULTS: 77 children (3.30 6 2.98 years old) with recently confirmed CMAwere enrolled. Four out of 75 subjects completing the DBPCFC with Control had an allergic reaction compared to 1 of 67 subjects during the DBPCFC with Test (lower bound 95% confidence interval of 0.921 for Test), meeting the AAP hypoallergenicity criteria. Average intake during the Test open challenge was 250ml/day. One subject reported angioedema, atopic dermatitis, rash around the eyes, and red swollen eyes on open challenge Day 6. This subject did not report any symptoms during the Test DBPCFC and did not discontinue formula during the open challenge. CONCLUSIONS: The new Test EHF meets the AAP criteria for hypoallergenicity and can be recommended for the management of CMA.