Safety of a formula supplemented with galacto-oligosaccharides in term infants

Infant formula design aims at achieving the same beneficial effects on physical and physiological development seen in breast-fed infants. The objective of this study was to evaluate the safety of an infant milk formula supplemented with GOS (0.4g/100mL) in terms of growth and incidence of adverse effects. This was a double blind, multicenter, parallel group, randomized clinical trial. Weight (g), length (cm), and occipito-frontal head circumference (cm) were measured. The incidence of adverse events (AEs) and infants acceptance and tolerance of the study formula were evaluated. A total of 199 breast fed infants and 163 formula fed (80 in the control and 83 in the study group) were recruited. All three groups showed appropriate physical development throughout the period. Length was significantly associated with breast-feeding. Diarrhea was comparably present in all groups. GOS supplemented formula stimulated infants' growth and prevented AEs similarly to human milk. Copyright © 2013 by New Century Health Publishers, LLC.