Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
2001-12-17
2004-09-28
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S093400, C435S856000
Reexamination Certificate
active
06797266
ABSTRACT:
FIELD OF THE INVENTION
The present invention discloses probiotic
Lactobacillus casei
preparations. Specifically, anti-infective, anti-diarrhea preparations derived from a newly characterized strain of
Lactobacillus casei
designated KE01 are disclosed. Related methods for preparing the probiotic compounds using
Lactobacillus casei
strain KE01 and related methods for using the KE01 probiotic compositions are also disclosed.
BACKGROUND OF THE INVENTION
The newly recognized probiotic
Lactobacillus casei
strain described herein has been designated KE01. Previously, this same organism had been designated
Lactobacillus casei
KE99 (see for example U.S. provisional application No. 60/256,528 and A. S. Naidu, X. Xie, D. A. Leumer, S. Harrison, M. J. Burrill and E. A. Fonda. 2001. Reduction of Sulfide, Ammonia Compounds and Adhesion Properties of
Lactobacillus casei
strain KE99 In Vitro. Curr. Microbiol. 43: In press.)
Lactic acid bacteria (LAB) are indigenous microflora of mammalian gastrointestinal tract that play an important role in the host microecology and have been credited with an impressive list of therapeutic and prophylactic properties. These therapeutic and prophylactic properties include, but not limited to the maintenance of microbial ecology of the gut, physiological, immuno-modulatory and antimicrobial effects. Other LAB associated attributes include enzyme release into the intestinal lumen that act synergistically with LAB adhesion to alleviate symptoms of intestinal malabsorption. Furthermore, the LAB enzymes help regulate intestinal pH which results in increased aromatic amino acid degradation. [Fuller, R. Probiotic foods—current use and future developments. IFI NR 3:23-26 (1993); Mitsuoka, T. Taxonomy and ecology of Bifidobacteria. Bifidobacteria Microflora 3:11 (1984); Gibson, G. R. et al., Probiotics and intestinal infections, p.10-39. In R. Fuller (ed.), Probiotics 2: Applications and practical aspects. Chapman and Hall, London, U.K. (1997); Naidu A S, et al., Probiotic spectra of lactic acid bacteria (LAB). Crit Rev Food Sci Nutr 39:3-126 (1999); Naidu, A. S., Clemens, R. A. Probiotics, p.431-462. In A. S. Naidu (ed.), Natural Food Antimicrobial Systems. CRC Press, Boca Raton, Fla. (2000)]
Lactic acid bacteria have also demonstrated the ability to significantly reduce sulfide and ammonia containing compounds in animal fecal waste and thus reduce the odor and toxicity associated with animal excrements. This ex vivo LAB application is becoming increasingly more important as agro-businesses expand and as communities continue their seemingly never ending encroachment into previously unoccupied rural areas. For example, LAB has been demonstrated to eliminate offensive odors and reduce hydrogen sulfide production associated with hatchery waste when cockerel chicks and shell waste are blended with a mixture containing 15% carbohydrate and LAB. Moreover, LAB compositions have demonstrated efficacy in diminishing the
Escherichia coli
and Salmonella content of hatchery waste to negligible levels. Additionally, the odor and viscosity of poultry offals such as broiler-processing waste is significantly reduced by
L. acidophilus
mediated lactic acid fermentation. Furthermore, preparations containing LAB have been reported to accelerate the breakdown of hard-to-degrade carbohydrates and decrease the ammonia production by porcine cecal bacteria. Finally, ex vivo
L. casei
FG1 and
L. plantarum
FG10 silage fermentation significantly reduces ammonia levels by inhibiting urea-splitting organisms. [Deshmukh, A. C., Patterson, P. H. Preservation of hatchery wastes by lactic acid fermentation. 1. Laboratory scale fermentation. Poult Sci 76:1212-1219 (1997); Russell, S. M. et al., Lactic acid fermentation of broiler processing waste: physical properties and chemical analyses. Poult Sci 71:765-770 (1992); Tibbetts, G. W. et al., Poultry offal ensiled with
Lactobacillus acidophilus
for growing and finishing swine diets. J Anim Sci 64:182-190 (1987); Sakata, T. et al., Probiotic preparations dose-dependently increase net production rates of organic acids and decrease that of ammonia by pig cecal bacteria in batch culture. Dig Dis Sci 44:1485-1493 (1999); Cai, Y. et al., Effect of applying lactic acid bacteria isolated from forage crops on fermentation characteristics, aerobic deterioration of silage. J Dairy Sci 82:520-526 (1999); Modler, H. W. et al., Bifidobacteria and bifidogenic factors. Can Inst Food Sci Tech 23:29-41 (1990)].
However, the greatest potential for LAB to improve life quality for man and domestic animals lies in LAB in vivo probiotic applications. In order for LAB to exhibit beneficial probiotic effects in vivo, the organisms must survive for extended time periods in the gastrointestinal tract. Therefore, it is critical that probiotic LAB strains be selected that possess qualities that prevent their rapid removal by gut contraction. Effective probiotic bacteria must able to survive gastric conditions and colonize the intestine, at least temporarily, by adhering to the intestinal epithelium. Consequently, LAB that demonstrate an enhanced ability to adhere to mucosal surfaces, and therefore possess improved bacterial maintenance and prolonged gastrointestinal tract residence times, have a competitive advantage over LAB that do not. [Salminen, S. et al., Clinical uses of probiotics for stabilizing the gut mucosal barrier: successful strains and future challenges. Antonie Van Leeuwenhoek 70:347-358 (1996); Conway, P. Selection criteria for probiotic microorganisms. Asia Pacific J Clin Nutr 5:10-14 (1996); Havenaar, R. et al., Selection of strains for probiotic use, p.209-224. In R. Fuller (ed.), Probiotics, the scientific basis. Chapman and Hall, London, U.K. (1992)].
Lactobacillus can successfully colonize the mammalian gastrointestinal tract through a number of different mechanisms. For example, some bacterial species bind to various sub-epithelial matrix proteins and specific receptors on the intestinal mucosa. Other species may adhere to mammalian intestinal cells via mechanisms that involve different combinations of carbohydrate and protein factors on the bacteria and host eucaryotic cell surfaces. However, regardless of the mechanism(s) of attachment, it is the ability of LAB to successfully colonize the human gastrointestinal tract that provides LAB with probiotic qualities. [Greene, J. D., Klaenhammer, T. R. Factors involved in adherence of lactobacilli to human Caco-2 cells. Appl Environ Microbiol 60:4487-4494 (1994); Sarem, F. et al., Comparison of the adherence of three Lactobacillus strains to Caco-2 and Int-407 human intestinal cell lines. Lett Appl Microbiol 22:439-442 (1996); Naidu, A. S., et al., Particle agglutination assays for rapid detection of fibronectin, fibriogen, and collagen receptors on
Staphylococcus aureus
. J Clin Microbiol 26:1549-1554 (1988); Wadstrom, T. et al., Surface properties of lactobacilli isolated from the small intestines of pigs. J Appl Bacteriol 62:513-520 (1987); Bernet, M. F. et al.,
Lactobacillus acidophilus
LA 1 binds to cultured human intestinal cell lines and inhibits cell attachment, invasion by entero-virulent bacteria. Gut 35:483-489 (1994); Jin, L. Z. et al., Effect of adherent Lactobacillus spp. on in vitro adherence of salmonellae to the intestinal epithelial cells of chicken. J Appl Bacteriol 81:201-206 (1996); Reid, G. et al., Influence of lactobacilli on the adhesion of
Staphylococcus aureus
and
Candida albicans
to fibers and epithelial cells. J Ind Microbiol 15:248-253 (1995)].
Generally speaking probiotic bacteria exert their beneficial effects by displacing invasive or toxigenic pathogenic enteric bacteria (enteric pathogens) from the intestinal mucosa through a competitive binding process. Enteric pathogens such as, but not limited to enteropathogenic
Escherichia coli
(EPEC), enterotoxigeneic
E. coli
(ETEC),
Salmonella enteriditis, Yersina pseudotuberculosis
and
Listeria monocytogenes
must be able to successively colonize an animal's
Cullman Louis C.
Naff David M.
Preston Gates & Ellis LLP
Probiohealth
Ware Deborah K.
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