New species and strains of probiotic bacteria are becoming commercially available as dietary ingredients in both food supplements and functional foods. It is especially important that novel probiotics are properly tested for safety and efficacy. The focus of this paper is to present a comprehensive toxicological assessment to support the safety for chronic consumption of the novel probiotic GanedenBC30. It has been demonstrated that some strains of Bacillus coagulans can survive extremes of heat, acidity of the stomach and bile acids, to which commonly consumed probiotics are susceptible. A toxicological safety assessment was performed on a proprietary preparation of B. coagulans – GanedenBC30 - a novel probiotic. Seven toxicologic studies were conducted and included: in vitro bacterial reverse mutation assay; in vitro chromosomal aberration assay; micronucleus assay in mice; acute and 90 day subchronic repeated oral toxicity studies were also conducted. The results of this toxicological safety assessment indicate that GanedenBC30 B. coagulans does not demonstrate mutagenic, clastogenic, or genotoxic effects. Furthermore, the results of the acute and 90-day subchronic oral toxicity studies in rats resulted in the conclusion of a no observable adverse effect level (NOAEL) greater than 1000 mg/kg per day. Based upon scientific procedures and supported by history of use, GanedenBC30 is considered safe for chronic human consumption.
Endres JR, Clewell A, Jade KA, Farber T, Hauswirth J, Schauss AG.
Food and Chemical Toxicology 2009;47 (6): 1231-1238