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  Use of lactobacillus salivariusUSPTO Application #: 20060292133Title: Use of lactobacillus salivarius Abstract: Lactobacillus salivarius is useful in the prophylaxis or treatment of undesirable inflammatory activity, especially gastrointestinal inflammatory activity such as inflammatory bowel disease or irritable bowel syndrome. The inflammatory activity may also be due to cancer. The Lactobacillus salivarius is of human origin isolated from resected and washed human gastrointestinal tract. One such strain is UCC 118 described in WO-A-9835014. (end of abstract) Agent: Jacobson Holman PLLC - Washington, DC, US Inventors: John Kevin Collins, Gerald Christopher O'Sullivan, Liam O'Mahony, Fergus Shanahan USPTO Applicaton #: 20060292133 - Class: 424093450 (USPTO) Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Whole Live Micro-organism, Cell, Or Virus Containing, Bacteria Or Actinomycetales, Lactobacillus Or Pediococcus Or Leuconostoc The Patent Description & Claims data below is from USPTO Patent Application 20060292133. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This is a Continuation of application Ser. No. 10/804,223, filed Mar. 19, 2004, which in turn is a Continuation of application Ser. No. 10/241,797, filed Sept. 12, 2002, which in turn is a Continuation of application Ser. No. 09/903,590, filed Jul. 13, 2001, now abandoned; which in turn is a Continuation of PCT/IE00/00007, filed Jan. 17, 2000. INTRODUCTION [0002] The invention relates to the use of strains of Lactobacillus salivarius. [0003] The defense mechanisms to protect the human gastrointestinal tract from colonization by intestinal bacteria are highly complex and involve both immunological and non-immunological aspects (V. J. McCracken and H. R Gaskins, `Probiotics a critical review`, Horizon Scientific Press, UK, 1999, p 278.). Innate deference mechanisms include the low pH of the stomach, bile salts, peristalsis, much layers and anti-microbial compounds such as lysozyme (D. C. Savage, `Microbial Ecology of the Gut`, Academic Press, London, 1997, p.278.). Immunological mechanisms include specialised lymphoid aggregates, underlying M cells, called peyers patches which are distributed throughout the small intestine and colon (M. F. Kagnoff. Gastrocaterol. 1993, 105, 1275). Luminal antigens presented at these sites result in stimulation of appropriate T and B cell subsets with establishment of cytoline networks and secretion of antibodies into the gastrointestinal tract (M. R. Neutra and J-P Kraehenbuhl, `Essentials of mucosal immunology`, Academic Press, San Diego, 1996, p.29., M. E. Lamm. Ann. Rev. Mirobiol. 1997, 51, 311). In addition, antigen presentation may occur via epithelial cells to intraepithelial lymphocytes and to the underlying lamina propria immune cells (S. Raychaudhur et al. Nat Biotecinol., 1998, 16, 1025). Therefore, the host invests substantially in immunological defense of the gastrointestinal tract. However, as the gastrointestinal raucous is the largest surface at which the host interacts with the external environment, specific control mechanisms must be in place to regulate immune responsiveness to the 100 tons of food which is handled by the gastrointestinal tract over an average lifetime (F. Shanahan, `Physiology of the gastrointestinal tract`, Raven Press, 1994, p.643.). Furthermore, the gut is colonised by over 500 species of bacteria numbering 10.sup.11-10 .sup.12/g in the colon. Thus, these control mechanisms must be capable of distinguishing non-pathogenic adherent bacteria from invasive pathogens which would cause significant damage to the host. In fact, the intestinal flora contributes to defence of the host by competing with newly ingested potentially pathogenic micro-organisms. [0004] Consumption of non-pathogenic, or probiotic, bacteria has resulted in enhancement of immune parameters in healthy volunteers. Examples of these immune modulatory effects are given in Table 1. TABLE-US-00001 TABLE 1 Immune Enhancing Effects Following Oral Consumption of Probiotic Bacteria. Observed Effect Reference Increased Macrophage Phagocytosis 10 Increased Natural Killer Cell Activity 11 Increased IFN.gamma. serum levels 12 Increased B cell and NK cell numbers 12 Promotion of IgA responses 11, 13-15 Increased DTH responses 16 [0005] Bacteria present in the human gastrointestinal tract can promote inflammation. Aberrant immune responses to the indigenous microflora have been implicated in certain disease states, such as inflammatory bowel disease (Brandzeag P. et al. Springer Semin. Immunopathol., 1997, 18, 555). Antigens associated with the normal flora usually lead to immunological tolerance and failure to achieve this tolerance is a major mechanism of mucosal inflammation (Stallmach A. et al., Immunol. Today, 1998, 19, 438). Evidence for this breakdown in tolerance includes an increase in antibody levels directed against the gut flora in patients with lBD. WO-A-98/35014 describes strains of Lactobacillus salivarius isolated from resected and washed human gastrointestinal tract which inhibits a broad range of Gram positive and Gram negative microorganisms and which secretes a product having anti-microbial activity into a cell-free supernatant. STATEMENTS OF INVENTION [0006] The immune system is designed to defend host tissue and destroy invading pathogens. Upon recognition of the presence of a bacterial cell, cells of the immune system become activated and eliminate the bacterial threat. The production of inflammatory mediators promote cellular activation and pathogen destruction. [0007] Surprisingly, we have found that strains of Lactobacillus salivarius elicit an anti-inflammatory effect in viro and in vivo. We have found that the immune perception of Lactobacillus salivarius results in the suppression of inflammatory activity. The deliberate consumption in large numbers of Lactobacillus salivarius results in the suppression of inflammatory activity. The invention is therefore of major potential therapeutic value in the prophylaxis or treatment of undesirable inflammatory responses, such as inflammatory bowel disease. [0008] Lactobacillus salivarius is a commensal microorganism originally isolated from the microbial flora within the human gastrointestinal tract. The immune system within the gastrointestinal tract cannot have a pronounced reaction to members of this flora as the resulting inflammatory activity would also destroy host cells and tissue function. Therefore, some mechanism(s) exist whereby the immune system can recognise commensal non-pathogenic members of the gastrointestinal flora as being different to pathogenic organisms. This ensures that damage to host tissues is restricted and a defensive barrier is still maintained. [0009] According to the invention there is provided use of a strain of Lactobacillus salivarius in the prophylaxis and/or treatment of undesirable inflammatory activity. [0010] The invention the undesirable inflammatory activity may be undesirable gastrointestinal inflammatory activity such as inflammatory bowel disease, eg. Crohns disease, ulcerative colitis, irritable bowel syndrome, pouchitis or post infection colitis. [0011] The gastrointestinal inflammatory activity may also be diarrhoeal disease. The diarrhoeal disease may be associated by Clostridium difficile or be associated with Rotovirus. The diarrhoeal disease may also be post infective diarrhoeal disease. [0012] The inflammatory activity may be due to gastrointestinal cancer or systemic inflammatory disease such as rheumatoid arthritis. [0013] In another instance the undesirable inflammatory activity may be due to an autoimmune disorder. [0014] In yet another instance the undesirable inflammatory activity may be due to cancer. [0015] In one embodiment the invention provides use of a strain of Lactobacillus salivarius in the prophylaxis of cancer. [0016] In another embodiment the invention provides use of a strain of Lactobacillus salivarius wherein the Lactobacillus salivarius is contained in a formulation. [0017] Preferably the formulation includes another probiotic material. Alternatively or additionally the formulation includes a prebiotic material. [0018] Ideally the formulation includes an ingestable carrier. The ingestable carrier may be a pharmaceutically acceptable carrier such as a tablet, capsule or powder. [0019] Preferably the ingestable carrier is a protein and/or a peptide, in particular proteins and/or peptides that are rich in glutamine/glutamate; a lipid; a carbohydrate; a vitamin; mineral and/or trace element. [0020] Most preferably the ingestable carrier is a food product such as acidified milk, yoghurt, frozen yoghurt, milk powder, milk concentrate, cheese spreads, dressings or beverages. [0021] In one embodiment the Lactobacillus salivarius is present in the formulation at more than 10.degree. cfu per gram of delivery system. [0022] In another embodiment the formulation includes an adjuvant. The formulation may include a bacterial component. The formulation may alternatively or additionally include a drug entity. The formulation may also include a biological compound. Continue reading... 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