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

Abstract

BackgroundTo ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants, advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow’s milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) or GOS alone.MethodsIn 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.ResultsThere 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.ConclusionsInvestigational 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.Trial registrationClinicalTrials.gov Identifier: NCT00712608

Prebiotics in infant formula

“…Comparing prebiotic enriched to standard infant formula, there were no group differences in growth rate between 14 to 120 d of age. 40 Discontinuation rates were not significantly different among study groups. 40 Tolerance of a formula enriched with FOS/GOS was excellent and no difference in growth parameters was observed after 6 and 12 weeks.…”

“…40 Discontinuation rates were not significantly different among study groups. 40 Tolerance of a formula enriched with FOS/GOS was excellent and no difference in growth parameters was observed after 6 and 12 weeks. 15 A transient increase in body weight was observed in children on prebiotics compared to controls during the first 6 months of follow-up.…”

“…softer stools) for infants in the PDX/GOS and GOS groups vs. controls and remained higher at 120 d for the PDX/GOS group (all P < 0.05). 40 When comparing Orafti Synergy1 (50 oligofructose: 50 FOS) 0.4 g/dL or 0.8 g/dL, GOS:FOS (90:10) 0.8 g/dL, or a standard formula, stool consistency of infants taking SYN1 0.8 g/dL or GOS/FOS-supplemented formula were closer to the breast-fed pattern. 16 In a large study in 1130 infants, the stool consistency in the prebiotic group was softer than in the control group at 8, 16 and 24 weeks (P < 0.001) and more similar to that of the breastfed group.…”

Scientific Opinion on nutrient requirements and dietary intakes of infants and young children in the European Union

“…They have also been studied in relation to any potential untowards effects, such as delayed growth, diarrhoea and an increased risk of inadequate water balance (SCF, 2003c;Ben et al, 2004;Decsi et al, 2005;Fanaro et al, 2005;Bettler and Euler, 2006;Moro et al, 2006;Ziegler et al, 2007;Costalos et al, 2008;Rao et al, 2009;Piemontese et al, 2011;Ashley et al, 2012).…”

“…galacto-oligosaccharides (GOS), inulin-type fructans or their combination or with mixtures of polydextrose (PDX) and acidic-oligosaccharides (AOS)) have been produced to be added to infant and follow-on formulae and have been studied for number of health outcomes, such as bowel function (Knol et al, 2005;Scholtens et al, 2006;Rao et al, 2009;Ashley et al, 2012), gastrointestinal and respiratory tract infections (Duggan et al, 2003;Brunser et al, 2006;EFSA NDA Panel, 2010e), atopic dermatitis, eczema, urticaria and asthma (Osborn and Sinn, 2007;EFSA NDA Panel, 2010e).…”