Abstract

Objective: A randomized, double-blind controlled study compared breastfeeding, partially- and extensively-hydrolyzed protein formulas (pHF and eHF) in their effect on cow' milk allergy (CMA) and atopic symptoms in infants at risk of allergy.Methods: Healthy, full-term infants were randomized to receive a whey pHF or a whey eHF, either exclusively from birth to 4 months of age or at weaning when mothers were willing to breastfeed child. The population consisted of 141 (ITT) and 104 (PP) children in the pHF group and 138 (ITT) and 90 (PP) in the eHF group, of whom respectively 40 (ITT) and 32 (PP) and 38 (ITT) and 31 (PP) were partially breastfed. At 4 months, a milk oral food challenge was performed and at 4 and 12 months, skin prick tests with various food antigens and plasma immunoglobulin concentrations were measured. Standard growth parameters were followed.Results: The incidences of CMA and of reactions to other food antigens were similarly low in all groups. Total IgE plasma concentrations increased between 4 and 12 months in all groups but increased significantly (p=0.048) less with pHF (16.92±47.11 kU/L) than with eHF (23.68±41.29 kU/L). There was an unexpectedly higher hemoglobin level in infants fed a pHF or an eHF compared to breastfeeding. Infants in all groups grew normally according to WHO standards.Conclusion: The whey pHF and the eHF reduced the risk of CMA and of atopic symptoms similarly. The pHF was superior in reducing IgE levels during the first year of life.

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