%0 Journal Article
%T Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial
%A Claude Ashley
%A William H Johnston
%A Cheryl L Harris
%A Suzanne I Stolz
%A Jennifer L Wampler
%A Carol Lynn Berseth
%J Nutrition Journal
%D 2012
%I BioMed Central
%R 10.1186/1475-2891-11-38
%X 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
%K Infant formula
%K Galactooligosaccharides
%K Polydextrose
%K Prebiotics
%U http://www.nutritionj.com/content/11/1/38/abstract