AN EVALUATION OF THE GROWTH OF TERM INFANTS FED FORMULA SUPPLEMENTED WITH FRUCTO-OLIGOSACCHARIDE

Abstract

The objectives of this work were to evaluate growth and tolerance in infants fed formula supplemented with fructo-oligosaccharide (FOS). Methods: The design was a randomized, masked, multicenter trial. Healthy term infants were randomly assigned to 1 of 3 formulas (a bovine milk-based control formula or identical experimental formulas supplemented with either 1.5 g/L or 3.0 g/L FOS) ad lib for 12 weeks. Anthropometric measurements were recorded at baseline and at 4, 8, and 12 weeks. Adverse events (AEs) and tolerance were recorded throughout the study, and blood samples were drawn at baseline and at 12 weeks for a clinical chemistry panel. Results: The study enrolled 297 infants, of whom 212 completed the trial. On the basis of percentiles and z scores, the infants were found to have grown appropriately, compared with the Centers for Disease Control and Prevention reference ranges. All 3 formulas were judged to be safe and well tolerated based on growth, laboratory data, and AE profiles. It is of clinical significance that the 3.0 g/ L FOS group had less constipation (P = 0.0333) than the other study groups. Conclusions: Bovine milk-based term formula supplemented with either 1.5 g/L or 3.0 g/L FOS is safe and supports normal growth.