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 .
Safety and efficacy of inulin and oligofructose supplementation in infant formula: results from a randomized clinical trial.
BACKGROUND & AIMS The sterile newborn digestive tract is rapidly colonized after birth and feeding type could influence this process . Infant formulas try to mimic the bifidogenic effect of human milk using prebiotic supplementation . The aim of this study was to demonstrate the efficacy , safety and tolerance of a 0.8 g/dL Orafti( ® )Synergy1 ( oligofructose-enriched inulin ) supplemented infant formula during the first 4 months of life . METHODS In a double-blind , r and omized , placebo-controlled and parallel trial , formula fed healthy term newborns were r and omized to receive a control ( controls ) or SYN1 supplemented infant formula ( SYN1 ) . Breastfed newborns ( BF ) were also followed for comparison . Anthropometry , water balance , blood parameters , adverse events , stool frequency and characteristics and faecal microbiota were assessed . RESULTS A total of 252 formula fed infants were r and omized at birth ( n = 124 controls , n = 128 SYN1 ) and 131 BF infants were recruited ; after 4 months 68 controls , 63 SYN1 and 57 BF completed the study . SYN1 infants showed a microbiota composition closer to that of BF infants , with a trend towards higher Bifidobacterium cell counts , softer stools and a higher deposition frequency compared to controls . There were no differences between formulas in anthropometry and relevant adverse events , water balance or blood parameters . CONCLUSION A 0.8 g/dL SYN1-supplemented infant formula during the first 4 months of life is safe and effective , promoting a gut microbiota closer to that of breastfeeding . This clinical trial was registered at Clinical trials.gov as Study on Fermentable Carbohydrates in Healthy Infants ( number NCT00808756 )
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 .