A randomised, double blind, placebo-controlled study on healthy newborn, full-term children. The aim was to study safety aspects following the daily intake of Lactobacillus reuteri given from the day of birth and the following 28 days.
Four groups of children were studied: Lactobacillus reuteri ATCC 55730 in the doses 10^5 CFU/day (n=12), 10^7 CFU/day (n=25) or 10^9 CFU/day (n=25), and placebo (n=28).
All dose levels of Lactobacillus reuteri were well tolerated. The degree of Lactobacillus reuteri colonisation, measured as the number of living cells in stool samples, was related to the given dose. The occurrence of watery diarrhoea was significantly lower in children given Lactobacillus reuteri.
Conclusion: Lactobacillus reuteri was safe to consume for healthy full-term newborns during their first four weeks of life, in doses up to 10^9 CFU/day.