Safety and tolerance of Lactobacillus reuteri Gastrus

The aim of this study was to assess the safety and tolerance of Lactobacillus reuteri Gastrus (L. reuteri ATCC PTA 6475 and L. reuteri DSM 17938). The results are presented in an internal report.

In this randomised, double-blind, placebo-controlled study, safety and tolerance were evaluated by blood parameters and a questionnaire regarding the incidence of gastrointestinal symptoms. The study included 20 healthy volunteers, divided into three groups. One group received L. reuteri Gastrus in a standard dose, one received a high dose of L. reuteri ATCC PTA 6475 (1×10¹¹ CFU/day) and one received placebo. Measurements were taken at the beginning of the study and after 28 days of supplementation.

All subjects completed the study. Blood safety parameters were all within normal ranges and the health questionnaire showed no untoward or unexpected adverse events in the study subjects.

Conclusions

L. reuteri Gastrus at the dose predicted to have clinical efficacy was well-tolerated when given daily for 28 days. Further, a 100-fold higher dose of L. reuteri ATCC PTA 6475 was also shown to be well-tolerated.