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 and Safety Evaluation in a Large Cohort of Healthy Infants Fed an Innovative Prebiotic Formula: A Randomized Controlled Trial
Background the addition of oligosaccharides to infant formula has been shown to mimic some of the beneficial effects of human milk . The aim of the study was to assess the tolerance and safety of a formula containing an innovative mixture of oligosaccharides in early infancy . Methodology /Principal Findings this study was performed as a multi-center , r and omized , double-blind , placebo-controlled trial including healthy term infants . Infants were recruited before the age of 8 weeks , either having started with formula feeding or being fully breast-fed ( breastfeeding group ) . Formula-fed infants were r and omized to feeding with a regular formula containing a mixture of neutral oligosaccharides and pectin-derived acidic oligosaccharides ( prebiotic formula group ) or regular formula without oligosaccharides ( control formula group ) . Growth , tolerance and adverse events were assessed at 8 , 16 , 24 and 52 weeks of age . The prebiotic and control groups showed similar mean weight , length and head circumference , skin fold thicknesses , arm circumference gains and stool frequency at each study point . As far as the anthropometric parameters are concerned , the prebiotic group and the control group did not attain the values shown by the breastfeeding group at any study point . The skin fold thicknesses assessed in the breastfeeding group at 8 weeks were strikingly larger than those in formula fed infants , whereas at 52 weeks were strikingly smaller . The stool consistency in the prebiotic group was softer than in the control group at 8 , 16 and 24 weeks ( p<0.001 ) and closer to that of the breastfeeding group . There was no difference in the incidence of adverse events between the two formula groups . Conclusions our findings demonstrate the tolerability and the long term safety of a formula containing an innovative mixture of oligosaccharides in a large cohort of healthy infants . Trial Registration : drks-neu.uniklinik-freiburg.de DRKS
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 .