Based on clinical data 1×10^8 CFU/day (100 million bacterial cells) has been chosen as a safe and efficacious dose ofLactobacillus reuteri in man. Further, since Lactobacillus reuteri colonization is transient, dosing should be maintained to ensure adequate and stable Lactobacillus reuteri levels in the gastrointestinal tract.
Lactobacillus reuteri is one of the most scientifically well-documented probiotics with regard to both efficacy and safety. Lactobacillus reuteri has been tested for host tolerance in term and preterm infants, children, healthy adults and immunosuppressed adults (HIV patients).
No adverse serious medical consequences have been observed up to the maximum tested dosage of 10^10 colony-forming units per day (10 billion CFU) and no significant differences in standard medical laboratory tests were found, including complete blood count, urinalysis, complete metabolic panel and liver function tests between those subjects given Lactobacillus reuteri and those given placebo.