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A probiotic containing a specific strain of the anaerobic, butyric acid-forming Gram-positive bacterium Clostridium butyricum (C. butyricum), with potential immunomodulatory, anti-inflammatory and antineoplastic activities. Clostridium butyricum MIYAIRI (CBM) 588 is the 588th MIYAIRI strain, isolated from a soil sample in Japan in 1963. Upon oral administration of C. butyricum CBM 588 probiotic strain, C. butyricum modulates the composition of the normal gastrointestinal (GI) microflora, by increasing the beneficial bacteria and decreasing the harmful bacteria, and helps maintain adequate colonization of the GI tract, thereby improving digestion and preventing GI disturbances. These bacteria and the butyric acid produced by them create an environment unfavorable to pathogens by adhering to human epithelial cells and forming a protective mucosal barrier. This prevents attachment of pathogens and reduces the risk of infection. By restoring gut microbiota, these bacteria may restore or enhance intestinal immune responses. C. butyricum induces interleukin-10-producing macrophages in inflamed mucosa via the Toll-like receptor 2 (TLR2)/myeloid differentiation primary response gene 88 (MyD88) pathway, thereby decreasing inflammatory responses. In addition, CBM588 may exert antineoplastic activity by inducing the release of the endogenous cytokine tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) from intracellular stores in polymorphonuclear neutrophils (PMNs), most likely involving matrix metalloproteinase 8 (MMP-8) and the Toll-like receptors (TLR)2/4 signaling pathways. This results in TRAIL-mediated induction of apoptosis in susceptible tumor cells.
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