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 .
Assessment of the safety, tolerance, and protective effect against diarrhea of infant formulas containing mixtures of probiotics or probiotics and prebiotics in a randomized controlled trial.
BACKGROUND Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants . OBJECTIVE The objective was to evaluate infant formulas containing probiotics and synbiotics ( combinations of probiotics and prebiotics ) for safety and tolerance . DESIGN In a prospect i ve , controlled , double-blind , r and omized trial , healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 ( BL999 ) + Lactobacillus rhamnosus LPR ( LPR ) , BL999 + LPR + 4 g/L of 90 % galactooligosaccharide/10 % short-chain fructooligosaccharide ( GOS/SCFOS ) , or BL999 + Lactobacillus paracasei ST11 ( ST11 ) + 4 g/L GOS/SCFOS from < or = 2 to 16 wk of age ( treatment period ) . Safety and tolerance were assessed based on weight gain during the treatment period ( primary outcome ) as well as recumbent length , head circumference , digestive tolerance , and adverse events ( secondary outcomes ) , which were evaluated at 2 , 4 , 8 , 12 , 16 , and 52 wk of age . RESULTS Two hundred eighty-four infants were enrolled . During the treatment period , difference in mean weight gain between control and study formula groups in both the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d , indicating equivalent weight gain . Secondary outcomes did not show significant differences between groups during the treatment period . CONCLUSION Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well
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 .