The administration of currently evaluated prebiotic-supplemented formulae to healthy infants does not raise safety concerns with regard to growth and adverse effects .
Some favourable clinical effects are possible , primarily stool softening , which may be beneficial in some infants .
Currently , there is no existing robust evidence to recommend the routine use of prebiotic-supplemented formulae .
In 2011 , the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology and Nutrition systematic ally review ed published evidence related to the safety and health effects of the administration of formulae supplemented with pro- and /or prebiotics compared with unsupplemented formulae .
Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial
Background To 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 design ed 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 . Methods In this multi-center , double-blind , parallel- design ed , gender-stratified prospect i ve study 419 infants were r and omized 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 . Results 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 . Conclusions 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 . Trial registration Clinical Trials.gov Identifier :
The administration of currently evaluated prebiotic-supplemented formulae to healthy infants does not raise safety concerns with regard to growth and adverse effects .
Some favourable clinical effects are possible , primarily stool softening , which may be beneficial in some infants .
Currently , there is no existing robust evidence to recommend the routine use of prebiotic-supplemented formulae .
In 2011 , the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology and Nutrition systematic ally review ed published evidence related to the safety and health effects of the administration of formulae supplemented with pro- and /or prebiotics compared with unsupplemented formulae .