Efficacy and Safety of Soy Protein Based Formula in Atopic Dermatitis

Abstract

Soy protein based formula (SPF) has been developed for infants who are at a high risk for atopic dermatitis (AD) and cow’s milk protein allergy (CMA). We performed this study to evaluate the therapeutic efficacy and safety of SPF compared to conventional hydrolyzed cow’s milk formula (hCMF) in the feeding of infants with AD and CMA. 38 infants (12 to 24 months of age) diagnosed with CMA and AD were randomized to receive either SPF or hCMF for 12 weeks. Follow-up was conducted at 4, 8 and 12 weeks. Growth parameters of the infants were evaluated during each visit. Clinical evaluations, including AD severity scores, pruritus, specific immunoglobulin E (IgE) (cow’s milk protein and soy protein) levels of peripheral blood, were made at enrollment and week 12. Analysis was performed on the 32 infants (SPF: n=16, hCMF: n=16) who completed the 12-week intervention. Eczema area and severity index (EASI) scores, a measure of the severity of AD, and pruritus were significantly reduced after 12 weeks compared to enrollment in the both groups; however, the median changes for EASI scores and pruritus were not statistically different between the two groups. The growth parameters did not differ significantly between both groups at any assessed time point. This study suggests that SPF could be useful in decreasing the severity of AD without affecting infant growth status. Therefore SPF could provide an adequate and safe alternative to hCMF in treating infants with AD and CMA during the first 12 to 24 months of their life.