Abstract
Objective: The American Academy of Pediatrics (AAP) defined an infant formula as hypoallergenic if it ensures with 95% confidence that 90% of infants/children with confirmed cow’s milk protein allergy (CMA) do not react under double-blind, placebo-controlled conditions. The aim of this study was to determine whether a new 100% whey protein extensively hydrolyzed formula containing B. lactis CNCM I-3446, meets AAP hypoallergenicity criteria. Methods: Children with CMPA were randomized to double-blind placebo-controlled food challenges (DBPCFC) with a new extensively hydrolyzed formula (Test) and a commercial extensively hydrolyzed formula (Control) in a cross-over fashion. CMPA was confirmed by elevated serum cow’s milk (CM)-IgE levels, positive skin prick test to CM extract, or positive CM oral challenge within 6 months prior to enrollment. Allergic reactions in the DBPCFC’s were assessed using a comprehensive scoring system. If both challenges were tolerated, subjects participated in an at-home week-long Test open challenge. Results: Seventy-seven children (3.30 ± 2.98 years old) with recently confirmed CMPA were enrolled. Of the 68 subjects participating in the Test DBPCFC, one had an allergic reaction (lower bound 95% confidence interval of 0.921 for Test), while 4 out of 75 subjects participating in the DBPCFC with Control had an allergic reaction. The Test formula met the AAP hypoallergenicity criteria. Average formula intake during the Test open challenge was 250ml/ day. One 6-year old 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, was not exclusively formula-fed during the open challenge, and did not discontinue formula during the open challenge. Conclusion: The new Test EHF meets the AAP criteria for hypoallergenicity and can be recommended for the management of CMPA.
Highlights
Cow’s milk protein is the leading food allergen in infants and young children younger than 3 years [1,2,3]
cow’s milk protein allergy (CMPA) had to be documented within 6 months prior to enrollment by either: 1) reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE (>0.7 kIU/L) or positive skin prick test; or 2) physician-supervised oral food challenge that elicited immediate allergic symptoms; or 3) serum milk IgE ≥ 15 [kIU/L]or ≥ 5 [kIU/L if younger than 1 year; or 4) skin prick tests mean wheal >10 mm [11,12,13]
It was later determined that three of these subjects did not have confirmed CMPA within 6 months of enrollment, and these subjects were excluded from the analysis; this population was defined as the modified Intention to Treat (ITT) population
Summary
Cow’s milk protein is the leading food allergen in infants and young children younger than 3 years [1,2,3]. The prevalence of cow’s milk protein allergy (CMPA) has been reported to range from 0.9% up to as high as 17% worldwide. In an extensive meta-analysis on food allergy prevalence conducted by Rona and colleagues, prevalence of selfreported cow’s milk hypersensitivity ranged from 1.2% to 17% [3]. The National Institute of Allergy and Infectious Diseases [4] report a CMPA prevalence of 3% for all ages, and 6-7% for children, relying upon the work of Rona and colleagues [3]. The allergic reactions that can occur following intact cow’s milk protein ingestion vary from cutaneous symptoms, to GI symptoms, respiratory symptoms and severe anaphylaxis
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