Probiotic, lactic acid-producing bacteria and uses thereof

Details Probiotic, lactic acid-producing bacteria and uses thereof Probiotic, lactic acid-producing bacteria and uses thereof

1999-08-05

2002-10-08

Weddington, Kevin E. (Department: 1614)

Drug, bio-affecting and body treating compositions

Whole live micro-organism, cell, or virus containing

Bacteria or actinomycetales

C424S093460, C514S030000, C514S192000, C514S199000, C514S200000, C514S307000, C514S770000, C514S029000

Reexamination Certificate

active

06461607

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to methods and compositions for the utilization of probiotic organisms in therapeutic compositions. More specifically, the present invention relates to the utilization of one or more species or strains of lactic acid-producing bacteria, preferably strains of
Bacillus coagulans
, for the control of gastrointestinal tract pathogens, including antibiotic-resistant gastrointestinal tract pathogens, and their associated diseases by both a reduction in the rate of colonization and the severity of the deleterious physiological effects of the colonization of the antibiotic-resistant pathogen. In addition, the present invention relates to the utilization of therapeutic compounds comprised of lactic acid-producing bacteria and anti-microbial agents such as antibiotics, anti-fungal compounds, anti-yeast compounds, or anti-viral compounds. In addition, the present invention relates to the use of lactic acid-producing bacteria in animals to mitigate gastrointestinal tract pathogens.
BACKGROUND OF THE INVENTION
1. Probiotic Microorganisms
The gastrointestinal microflora has been shown to play a number of vital roles in maintaining gastrointestinal tract function and overall physiological health. For example, the growth and metabolism of the many individual bacterial species inhabiting the gastrointestinal tract depend primarily upon the substrates available to them, most of which are derived from the diet. See e.g., Gibson G. R. et al., 1995
. Gastroenterology
106: 975-982; Christl, S. U. et al., 1992
. Gut
33: 1234-1238. These finding have led to attempts to modify the structure and metabolic activities of the community through diet, primarily with probiotics which are live microbial food supplements. The best known probiotics are the lactic acid-producing bacteria (i.e., Lactobacilli) and Bifidobacteria, which are widely utilized in yogurts and other dairy products. These probiotic organisms are non-pathogenic and non-toxigenic, retain viability during storage, and survive passage through the stomach and small intestine. Since probiotics do not permanently colonize the host, they need to be ingested regularly for any health promoting properties to persist. Commercial probiotic preparations are generally comprised of mixtures of Lactobacilli and Bifidobacteria, although yeast such as Saccharomyces have also been utilized.
Probiotic preparations were initially systematically evaluated for their effect on health and longevity in the early-1900's (see e.g., Metchinikoff, E.,
Prolongation of Life
, Willaim Heinermann, London 1910), although their utilization has been markedly limited since the advent of antibiotics in the 1950's to treat pathological microbes. See e.g., Winberg, et al, 1993
. Pediatr. Nephrol
. 7: 509-514; Malin et al,
Ann. Nutr. Metab
. 40: 137-145; and U.S. Pat. No. 5,176,911. Similarly, lactic acid-producing bacteria (e.g., Bacillus, Lactobacillus and Streptococcus species) have been utilized as food additives and there have been some claims that they provide nutritional and/or therapeutic value. See e.g., Gorbach, 1990
. Ann. Med
. 22: 37-41; Reid et al, 1990
. Clin. Microbiol. Rev
. 3: 335-344.
Therefore, probiotic microorganisms are those which confer a benefit when grow in a particular environment, often by inhibiting the growth of other biological organisms in the same environment. Examples of probiotic organisms include bacteria and bacteriophages which possess the ability to grow within the gastrointestinal tract, at least temporarily, to displace or destroy pathogenic organisms, as well as providing other benefits to the host. See e.g., Salminen et al, 1996
. Antonie Van Leeuwenhoek
70: 347-358; Elmer et al, 1996
. JAMA
275: 870-876; Rafter, 1995
. Scand. J. Gastroenterol
. 30: 497-502; Perdigon et al, 1995
. J. Dairy Sci.
78: 1597-1606; Gandi,
Townsend Lett. Doctors
&
Patients
, pp. 108-110, January 1994; Lidbeck et al, 1992
. Eur. J. Cancer Prev
. 1: 341-353.
The majority of previous studies on probiosis have been observational rather than mechanistic in nature, and thus the processes responsible for many probiotic phenomena have yet to be quantitatively elucidated. Some probiotics are members of the normal colonic microflora and are not viewed as being overtly pathogenic. However, these organisms have occasionally caused infections (e.g., bacteremia) in individuals who are, for example, immunocompromised. See e.g., Sussman, J. et al., 1986
. Rev Infect. Dis
. 8: 771-776; Hata, D. et al., 1988
. Pediatr. Infect. Dis
. 7: 669-671.
While the attachment of probiotics to the gastrointestinal epithelium is an important determinant of their ability to modify host immune reactivity, this is not a universal property of Lactobacilli or Bifidobacteria, nor is it essential for successful probiosis. See e.g., Fuller, R., 1989
. J. Appl. Bacteriol
. 66: 365-378. For example, adherence of
Lactobacillus acidophilus
and some Bifidobacteria to human enterocyte-like CACO-2 cells has been demonstrated to prevent binding of enterotoxigenic and enteropathogenic
Escherichia coli
, as well as
Salmonella typhimurium
and
Yersinia pseudotuberculosis
. See e.g., Bernet, M. F. et al., 1994
. Gut
35: 483-489; Bernet, M. F. et al., 1993
. Appl. Environ. Microbiol
. 59: 4121-4128.
While the gastrointestinal microflora presents a microbial-based barrier to invading organisms, pathogens often become established when the integrity of the microbiota is impaired through stress, illness, antibiotic treatment, changes in diet, or physiological alterations within the G.I. tract. For example, Bifidobacteria are known to be involved in resisting the colonization of pathogens in the large intestine. See e.g., Yamazaki, S. et al., 1982
. Bifidobacteria and Microflora
1: 55-60. Similarly, the administration of
Bifidobacteria breve
to children with gastroenteritis eradicated the causative pathogenic bacteria (i.e.,
Campylobacter jejuni
) from their stools (see e.g., Tojo, M., 1987
. Acta Pediatr. Jpn
. 29: 160-167) and supplementation of infant formula milk with
Bifidobacteria bifidum
and
Streptococcus thermophilus
was found to reduce rotavirus shedding and episodes of diarrhea in children who were hospitalized (see e.g., Saavedra, J. M., 1994
. The Lancet
344: 1046-109.
In addition, some lactic acid producing bacteria also produce bacteriocins which are inhibitory metabolites which are responsible for the bacteria's anti-microbial effects. See e.g., Klaenhammer, 1993
. FEMS Microbiol. Rev
. 12: 39-85; Barefoot et al., 1993
. J. Diary Sci
. 76: 2366-2379. For example, selected Lactobacillus strains which produce antibiotics have been demonstrated as effective for the treatment of infections, sinusitis, hemorrhoids, dental inflammations, and various other inflammatory conditions. See e.g., U.S. Pat. No. 5,439,995. Additionally,
Lactobacillus reuteri
has been shown to produce antibiotics which possess anti-microbial activity against Gram negative and Gram positive bacteria, yeast, and various protozoan. See e.g., U.S. Pat. Nos. 5,413,960 and 5,439,678.
Probiotics have also been shown to possess anti-mutagenic properties. For example, Gram positive and Gram negative bacteria have been demonstrated to bind mutagenic pyrolysates which are produced during cooking at a high temperature. Studies performed with lactic acid-producing bacteria has shown that these bacteria may be either living or dead, due to the fact that the process occurs by adsorption of mutagenic pyrolysates to the carbohydrate polymers present in the bacterial cell wall. See e.g., Zang, X. B. et al., 1990
. J. Dairy Sci
. 73: 2702-2710. Lactobacilli have also been shown to degrade carcinogens (e.g., N-nitrosamines), which may serve an important role if the process is subsequently found to occur at the level of the mucosal surface. See e.g., Rowland, I. R. and Grasso, P.,
Appl. Microbiol
. 29: 7-12. Additionally, the co-administration of lactulose and
Bifidobacteria longum
to rats injected with the carcinogen azoxymethane was demonstrated to reduce

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