CBM 588 was approved for clinical use in humans by the Japanese Ministry of Health and Welfare in 1970. The standard preparation as marketed by Miyarisan Pharmaceutical (Tokyo, Japan) consists of white, marked tablets each containing 0.35 × 106 colony forming units (CFU) of C. butyricum MIYAIRI 588 (as active agent). CBM 588 does not establish permanently in the gut, in common with other orally administered probiotic bacteria. CBM 588 for clinical use is produced by submerged anaerobic fermentation followed by centrifugation, drying, blending and packaging. The MIYAIRI 588 strain of C. butyricum does not carry any genes encoding any toxins and virulence factors associated with Clostridium or other enteropathogens. Absence of neurotoxin production has been demonstrated by polymerase chain reaction (PCR) and Southern blot hybridisation for type E botulinum toxin gene. The absence of genes encoding botulinum neurotoxin A,B,F and genes encoding non-toxic haemagglutinin (NTNH) and genes encoding Clostridium perfringens toxins (alpha, beta, epsilon and iota) has been demonstrated by PCR assay. This strain is deposited at the Fermentation Research Institute, Agency of Industrial Science and Technology, Japan under the strain name Clostridium butyricum MIYAIRI 588 strain, deposit number FERM BP-2789. Recent European Food Safety Authority opinions confirm the official strain nomenclature as Clostridium butyricum FERM BP-2789. Sources References External links Clostridium butyricum at BacDive Gram-positive bacteria Probiotics butyricum