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 breastfeeding.
Diarrhea was comparably present in all groups.
GOS supplemented formula stimulated infants’ growth and
prevented AEs similarly to human milk
