A randomized, single-blind and crossover study of an amino acid-based milk formula in treating young children with atopic dermatitis

Abstract

Cow's milk and soy protein allergies are commonly associated with atopic dermatitis (AD) in young children. Amino acid (AA)-based elemental milk formula may improve AD control in these patients. This study investigates the efficacy of AA-based formula in treating young AD patients irrespective of their food allergy status. AD patients younger than 3 yr old were eligible. Sensitization to food allergens was ascertained by skin prick tests and allergen-specific immunoglobulin E (IgE) assay. Patients were then randomly allocated to take either active treatment or pre-existing formulae (placebo) for 6 wk. They were allowed a 6-wk washout period before crossed over to the other intervention for another 6 wk. Fifteen AD patients, with median (interquartile range, IQR) age of 1.4 (0.6-2.6) yr, were recruited. Their median (IQR) SCORAD score was 23.9 (10.5-29.7). Seven of them were sensitized to cow's milk or soybean. Among 11 patients who completed the study, the median changes for all scores and urinary eosinophil protein X (EPX) concentration were not statistically significant. There was also no evidence of carry-over effects for SCORAD and its various components and global health score, except for urinary EPX concentration (p = 0.05). Our results do not support the use of AA-based elemental milk formula in treating young children with AD irrespective of their food allergy status.