Abstract

Objective: To assess growth of infants fed starter formula supplemented with either prebiotics or symbiotic. In addition, gut microbiota was studied. Methods: Healthy, full term newborns (n= 240) were enrolled before the 14th day of their life and randomly assigned between 3 exclusively formula fed groups: starter IF, starter IF + prebiotics (CMOS+GOS), starter IF + prebiotics (CMOS+GOS) and probiotics (BL999 + LPR). Growth was assessed by body weight gain during 4 months. Gut microbiota profile was examined by measuring fecal counts in Bifidobacteria, Lactobacilli, Enterobacteria, Clostridium at 2 months of age. Incidence of morbidity was appraised. Results: Non inferiority in growth was established between the two experimental groups and the control at the end of the 4 months intervention period. 90% confidence intervals for the effects of prebiotics versus control and symbiotic versus control were (-1.24, 3.17) and (-2.35, 2.02) respectively. Higher levels of fecal Bifidobacteria were observed in the experimental groups; this difference being significant between the symbiotic and control groups (8.8 +/-;1.7 versus 9.87+/-;1.2 p< 0.05). Furthermore, Clostridium levels were lower in both experimental vs control groups. No statistically significant differences of adverse events were detected between groups, except for a higher incidence of colics in the prebiotic and, to a lesser degree, in the symbiotic group vs control. Conclusion: Growth of newborns receiving IF containing prebiotics or symbiotic was non inferior to the growth observed in controls and within the limits defined by WHO growth reference curves. A bifidogenic effect due to symbiotic formulation was demonstrated.

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