Safety evaluation of excessive intake of the fermented milk containing the probiotic Lactobacillus gasseri SBT2055

Abstract

Objective: A randomized double-blind placebo-controlled study for 4 weeks was conducted to evaluate the safety for excessive intake of the fermented milk containing the probiotic Lactobacillus gasseri (L. gasseri) SBT2055 in healthy adults. Methods: Subjects (n=34 ; 14 male, 20 female) were asked to ingest 3 cups of fermented milk containing L. gasseri SBT2055 or placebo (100 g/cup) at one time per day for 4 weeks. Results: Changes in the body weight, BMI, vital signs and urine parameters were not observed in the test group during intake period. Although statistically significant increase in 3-hydroxybutyric acid, total ketone bodies, uric acid and potassium were observed after 4 weeks of intake in test group and significant difference between two groups was observed in serum calcium after 4 weeks of intake, these were considered to be no clinically concerning changes. No adverse event was observed during intake period in both groups. Conclusions: These results indicated the safety of the fermented milk containing L. gasseri SBT2055 in healthy adults when consumed excessively.