Safety of L. reuteri in neonates

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 L. reuteri given from the day of birth and the following 28 days. Four groups of children were studied: L. reuteri ATCC 55730 in the doses 10⁵ CFU/day (n=12), 10⁷ CFU/day (n=25) or 10⁹ CFU/day (n=25), and placebo (n=28). All dose levels of L. reuteri were well tolerated. The degree of L. 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 L. reuteri.

Conclusion: L. reuteri was safe to consume for healthy full-term newborns during their first four weeks of life, in doses up to 10⁹ CFU/day.

Reference

Safety and possible antidiarrhoeal effect of the probiotic Lactobacillus reuteri after oral administration to neonates. Karvonen A, Casas I, Vesikari T. (2001) Clin Nutr 20(suppl 3):63: abstract 216.