Isa K, Oka K, Beauchamp N, Sato M, Wada K, Ohtani K, Nakanishi S, McCartney E, Tanaka M, Shimizu T, Kamiya S, Kruger C, Takahashi M. Hum Exp Toxicol. 2015 Oct 5. pii: 0960327115607372. [Epub ahead of print]
Synopsis: Development of new live biotherapeutics includes the need for safety evaluations that should consider factors such as pathogenicity, infectivity, virulence factors, toxicity, and metabolic activity. Clostridium butyricum MIYAIRI 588® (CBM 588®), an anaerobic spore-forming bacterium, has been developed as a live biotherapeutic for use by humans. Safety studies of CBM 588 have been conducted and include assessment of antimicrobial sensitivity, documentation of the lack of Clostridium toxin genes, and evaluation of CBM 588® on reproductive and developmental toxicity in a rodent model. With the exception of aminoglycosides, to which anaerobes are intrinsically resistant, CBM 588® showed sensitivity to all antibiotic classes important in human and animal therapeutics. In addition, analysis of the CBM 588® genome established the absence of genes for encoding for α, β, or ε toxins and botulin neurotoxins types A, B, E, or F. There were no deleterious reproductive and developmental effects observed in mice associated with the administration of CBM 588®. These data provide further support for the safety of CBM 588® for use as a probiotic in animals and humans.