Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial.

The addition of probiotics to infant formula has been shown to be an efficient way to increase the number of beneficial bacteria in the intestine in order to promote a gut flora resembling that of breast-fed infants. The objective of the present study was to evaluate the safety and tolerance of a combination of two probiotic strains in early infancy. A group of 126 newborns were randomised to receive a prebiotic-containing starter formula supplemented with Lactobacillus paracasei ssp. paracasei and Bifidobacterium animalis ssp. lactis or the same formula without probiotics for the first 3 months of life. A total of eighty infants continued the study until they were aged 6 months. Growth measurements were taken monthly at healthy baby clinics. Diaries were used to monitor behaviour, infections, use of antibiotics, as well as stool characteristics. Normal growth occurred in all infants and no statistically significant differences were detected between the probiotics group and the control group for gain in weight, length and head circumference. Infants in the probiotics group produced softer and more frequent stools during the first 3 months of life. No differences were found in crying and sleeping hours, number of parent-diagnosed infections, antibiotic use, visits to the general practitioner and number of adverse events. The use of a prebiotic-containing starter formula supplemented with L. paracasei ssp. paracasei and B. animalis ssp. lactis in early infancy is safe, well tolerated and has no adverse effects on growth and infant behaviour.