Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial

In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 419 infants were randomized and consumed either a marketed routine cow’s milk-based infant formula (Control; Enfamil？ LIPIL？, Mead Johnson Nutrition, Evansville, IN) (n？=？142) or one of two investigational formulas from 14 to 120？days of age. Investigational formulas were supplemented with 4？g/L (1:1 ratio) of a prebiotic blend of PDX and GOS (PDX/GOS; n？=？139) or 4？g/L of GOS alone (GOS; n？=？138). Anthropometric measurements were taken at 14, 30, 60, 90, and 120？days of age. Daily recall of formula intake, tolerance, and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60, 90, and 120？days of age. Medically-confirmed adverse events were recorded throughout the study.There were no group differences in growth rate from 14 to 120？days of age. Discontinuation rates were not significantly different among study groups. No differences in formula intake or infant fussiness or gassiness were observed. During study weeks 1 and 2 and at 60？days of age stool consistency ratings were higher (i.e. softer stools) for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120？days for the PDX/GOS group (all P？<？0.05). The overall incidence of medically-confirmed adverse events was similar among groups.Investigational routine infant formulas supplemented with 4？g/L of either a prebiotic blend of PDX and GOS or GOS alone were well-tolerated and supported normal growth. Compared to infants who received the unsupplemented control formula, infants who received prebiotic supplementation experienced a softer stooling pattern similar to that reported in breastfed infants.ClinicalTrials.gov Identifier: NCT00712608