| Clostridium butyricum | |
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| C. butyricum MIYAIRI 588 tablets produced by Miyarisan Pharmaceutical, Tokyo, Japan (Chinese OTC packaging). | |
Scientific classification | |
| Domain: | Bacteria |
| Kingdom: | Bacillati |
| Phylum: | Bacillota |
| Class: | Clostridia |
| Order: | Eubacteriales |
| Family: | Clostridiaceae |
| Genus: | Clostridium |
| Species: | C. butyricum |
| Binomial name | |
| Clostridium butyricum Prazmowski 1880 (Approved Lists 1980) | |
Clostridium butyricum is a strictlyanaerobicendospore-formingGram-positivebutyric acid–producingbacillus subsisting by means offermentation using anintracellularly accumulated amylopectin-like α-polyglucan (granulose) as asubstrate. It is uncommonly reported as a human pathogen and is widely used as aprobiotic in Japan, Korea, and China.[1]C. butyricum is a soil inhabitant in various parts of the world, has been cultured from the stool of healthy children and adults, and is common in soured milk and cheeses.[2] The connection withdairy products is shown by the name, thebutyr- inbutyricum reflects the relevance ofbutyric acid in the bacteria's metabolism and the connection with Latinbutyrum and Greekβούτυρον, with word roots pertaining to butter and cheese.[3]
The study offermentation in the 19th century was of interest not only tobasic science but also asapplied science funded by companies in certain industries, principallywinemaking andbrewing, as a means to reduce risk of bad batches through greater understanding and control of the process. Thus, earlymicrobiologists such asLouis Pasteur were funded in their research into microbial metabolism and biochemistry. Such research led to the first understanding ofanaerobic metabolism,[3] andbutyric acid fermentation was humans' initial window into that world.[3] In 1880, Adam Prażmowski from the University of Leipzig first assigned the binomial nameClostridium butyricum.[3][4]
The firstC. butyricum MIYAIRI strain was isolated by Dr. Chikaji Miyairi from feces in Japan in 1933.[5] In 1963, CBM 588 was isolated from a soil sample inNagano, Japan.[5] Preparations based on CBM 588 have a long history of safe use in human populations in Japan, where such products are variously classed as pharmaceutical drugs, "quasi drugs", and OTC (Over The Counter) probiotics. The safe therapeutic use of CBM 588 in humans populations is supported by various peer-reviewed publications and case studies, including reports of CBM 588 use in severely-ill, immunocompromised, and hospitalized patients, as well as in pregnant women.[6][7][8][9]
Its usefulness stems primarily from its ability to interfere with the growth of highly pathogenicClostridioides difficile by antagonizing its multiplication.[10] It is often used in Japanese hospitals forC. difficile prophylaxis among in-patients and, particularly, during administration of certain powerful antibiotics (i.e.Levofloxacin) associated with opportunisticC. difficile infection.
CBM 588 was approved for clinical use in humans by the Japanese Ministry of Health and Welfare in 1970.[11] The standard preparation as marketed by Miyarisan Pharmaceutical (Tokyo, Japan) consists of white, marked tablets each containing 0.35 million colony forming units (CFU) ofC. 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.[9]
The MIYAIRI 588 strain ofC. butyricum does not carry any genes encoding any toxins and virulence factors associated withClostridium or other enteropathogens.[12] Absence of neurotoxin production has been demonstrated bypolymerase chain reaction (PCR) andSouthern blot hybridisation for type Ebotulinum toxin gene. The absence of genes encoding botulinumneurotoxin A,B,F and genes encoding non-toxic haemagglutinin (NTNH) and genes encodingClostridium 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 nameClostridium butyricum MIYAIRI 588 strain, deposit number FERM BP-2789. RecentEuropean Food Safety Authority opinions confirm the official strain nomenclature asClostridium butyricum FERM BP-2789.
In addition, otherC. butyricum strains have been discovered, including RH2,[13] S-45-5,[14] UBCB 70,[15] and CGMCC0313,[16] and used in different fields.
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