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 .
Tolerance of Formulas Containing Prebiotics in Healthy, Term Infants
Objective : The aim of the study was to compare infants ’ gastrointestinal tolerance of formulas supplemented with 2 different levels of galacto-oligosaccharides ( GOS ) versus a control formula ( CF ) or human milk . Methods : Healthy , full-term infants ( n = 180 ) were enrolled in this 3-group controlled , double-blind , multicenter study , and a concurrently enrolled ,  nonr and omized human milk – fed group ( HM ) by 8 days of age . Infants were r and omized to be fed formula supplemented with either 4 g ( EF4 ) or 8 g ( EF8 ) GOS/L or a CF until day of life ( DOL ) 119 . Infants were to be seen at DOL 14 , 35 , 56 , 84 , and 119 . Parents were to record detailed 24-hour information about intake , tolerance to feedings , and stool patterns and consistency each day from enrollment to DOL 35 , and for 3 days before DOL 56 , 84 , and 119 . Stool consistency was scored on a 5-point scale as watery ( 1 ) , loose/mushy , soft , formed , or hard ( 5 ) . Results : The mean stool consistency score was higher in the CF group throughout the study ( CF > EF8 and CF > HM for all study periods and CF > EF4 from DOL 15 to 35 , P < 0.05 ) . There was a significantly higher percentage of watery stools in the EF8 versus the CF group from study day 1 ( SD 1 ) to DOL 14 ( P < 0.05 ) , but no differences between the groups in number of stools per day . The percentage of feedings with spit up and /or vomiting within 1 hour after feeding was significantly lower for HM versus EF8 and CF from SD 1 to DOL 14 ( P < 0.05 ) . Conclusions : In this clinical study , milk-based term infant formula ( Similac Advance ) with 4 g GOS/L was well-tolerated in terms of stool consistency and additional measures of gastrointestinal tolerance by newborn infants through the first 4 months of life
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 .