Safety of Lactobacillus 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 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.

ConclusionLactobacillus 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.



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

Crawling baby

For the avoidance of doubt, BioGaia’s products are food supplements, and the information on this part of the website should not be interpreted as our products are intended to diagnose, treat, cure or prevent any disease.

The information on this part of the website is intended only for health care and business professionals. If you are not a health care or business professional and would like to learn more about the indications BioGaia works with, please visit our Expertise pages.

Please read terms & conditions before accepting. By clicking on the button “I acknowledge and accept” you confirm that you are a healthcare or business professional and have read and understood this disclaimer including the terms and conditions.