On the basis of this review , available scientific data suggest that the administration of currently evaluated probiotic- and /or prebiotic-supplemented formula to healthy infants does not raise safety concerns with regard to growth and adverse effects .
Infant formulae are increasingly supplemented with probiotics , prebiotics , or synbiotics despite uncertainties regarding their efficacy .
The present article , developed by the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology , and Nutrition , systematic ally review s published evidence related to the safety and health effects of the administration of formulae supplemented with probiotics and /or prebiotics compared with unsupplemented formulae .
Clinical evaluation of a new starter formula for infants containing live Bifidobacterium longum BL999 and prebiotics.
OBJECTIVES The larger number of bifidobacteria in the intestine of breast-fed infants has been associated with their better health compared with formula-fed infants . We assessed the safety and tolerability of an experimental formula containing 2 x 10(7 ) colony-forming units of Bifidobacterium longum BL999 and 4 g/L of a prebiotic mixture containing 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides . METHODS A 7-mo prospect i ve , r and omized , reference-controlled , double-blinded trial was performed in infants who were not breast fed after the 14th day of birth . One hundred thirty-eight infants were enrolled and assigned to receive the control or experimental formula until they were 112 d old .  Mean weight gain ( primary outcome ) and recumbent length , head circumference , tolerability ( gastrointestinal symptoms ) , and overall morbidity ( secondary outcomes ) were measured at 14 , 28 , 56 , 84 , and 112 d of age . RESULTS Equivalence in mean weight gain between the two groups was shown . The treatment difference in the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d . No statistically significant difference in recumbent length , head circumference , or incidence of adverse events was found between the two groups . Infants in the experimental group had fewer incidences of constipation and had stool characteristics that suggest that the experimental formula was tolerated well . Furthermore , these infants showed a trend toward fewer respiratory tract infections . CONCLUSIONS The starter formula containing BL999 and galacto-oligosaccharides/fructo-oligosaccharides is safe and well-tolerated
On the basis of this review , available scientific data suggest that the administration of currently evaluated probiotic- and /or prebiotic-supplemented formula to healthy infants does not raise safety concerns with regard to growth and adverse effects .
Infant formulae are increasingly supplemented with probiotics , prebiotics , or synbiotics despite uncertainties regarding their efficacy .
The present article , developed by the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology , and Nutrition , systematic ally review s published evidence related to the safety and health effects of the administration of formulae supplemented with probiotics and /or prebiotics compared with unsupplemented formulae .