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 .
Galacto-oligosaccharides Are Bifidogenic and Safe at Weaning: A Double-blind Randomized Multicenter Study
Objectives : The primary objective of this study was to determine the bifidogenic effect of galacto-oligosaccharides ( GOS ) in a follow-on formula and the effects on other intestinal bacteria . Secondary objectives were the effects on stool characteristics , growth , and general well-being . Participants and Methods : In a multicenter , double-blind study , 159 healthy infants , formula-fed at enrollment ( at 4–6 months ) , were r and omized to an experimental follow-on formula supplemented with 5 g/L ( GOS ) ( 77 infants ) , or to a st and ard follow-on formula ( control , 82 infants ) . Infants were evaluated at enrollment ( study day 1 = sd1 ) , after 6 weeks ( study day 2 = sd2 ) , and after an additional 12 weeks ( study day 3 = sd3 ) . At each study day , a fresh stool sample for the bacterial counts was collected , and the growth parameters were measured . At sd2 , urinary specimens were collected for the evaluation of urinary osmolarity . Results : At sd2 and sd3 , the GOS group had a higher median number ( colony-forming units per gram of stool ) of bifidobacteria than did the control group ( sd2 GOS 9.2 × 109 vs control 4.4 × 109 , P = 0.012 ) ; ( sd3 GOS 7.2 × 109 vs control 2.4 × 109 , P = 0.027 ) . Other bacteria did not show any significant differences between the 2 groups at all study days . The GOS produced softer stools but had no effect on stool frequency . The urinary osmolarity ( mOsm/L ) at sd2 was comparable in both groups . Supplementation had no influence on the incidence of gastrointestinal side effects or on the growth of the infants . Conclusions : These data indicate that the addition of GOS ( 5 g/L ) to a follow-on formula positively influences the bifidobacteria flora and the stool consistency in infants during the supplementation period at weaning . No local or systemic side effects were recorded
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 .