Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2001-04-06
2004-11-02
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S093460, C424S600000, C424S617000, C435S252500
Reexamination Certificate
active
06811786
ABSTRACT:
TECHNICAL FIELD
This invention relates to utilizing a probiotic organism in a therapeutic composition, and specifically relates to the use of a lactic acid-producing bacteria, preferably
Bacillus coagulans
spores, for control and reduction of serum cholesterol.
BACKGROUND OF THE INVENTION
Probiotic agents are organisms that confer a benefit when they grow in a particular environment, often by inhibiting the growth of other biological organisms in the same environment. Examples of probiotics include bacteria and bacteriophages which can grow in the intestine, at least temporarily, to displace or destroy pathogens and provide other benefits to the host organism (Salminen et al,
Antonie Van Leeuwenhoek,
70 (2-4): 347-358, 1996; Elmer et al,
JAMA,
275:870-876, 1996; Rafter,
Scand. J. Gastroenterol.,
30:497-502, 1995; Perdigon et al,
J. Dairy Sci
., 78:1597-1606, 1995; Gandi,
Townsend Lett. Doctors
&
Patients
, pp. 108-110, January 1994; Lidbeck et al,
Eur J. Cancer Prey.
1:341-353, 1992).
The therapeutic use of probiotic bacteria, especially
Lactobacillus
strains, that colonize the gut has been previously disclosed (Winberg et al,
Pediatr, Nephrol,
7:509-514, 1993; Malin et al,
Ann. Nutr. Metab.
40:137-145, 1996; and U.S. Pat. No. 5,176,911).
Lactic acid producing bacteria (e.g.,
Bacillus, Lactobacillus
and
Streptococcus
species) have been used as food additives and there have been some claims that they provide nutritional and therapeutic value (Gorbach,
Ann. Med.
22:37-41, 1990; Reid et al,
Clin. Microbiol. Rev.,
3:335-344, 1990).
Bacillus coagulans
is a non-pathogenic gram positive spore-forming bacteria that produces L(+) lactic acid (dextrorotatory) in homofermentation conditions. It has been isolated from natural sources, such as heat-treated soil samples inoculated into nutrient medium (
Bergey's Manual of Systemic Bacteriology
, Vol. 2, Sneath, P.H.A. et al., eds., Williams & Wilkins, Baltimore, Md., 1986). Purified
B. coagulans
strains have served as a source of enzymes including endonucleases (e.g., U.S. Pat. No. 5,200,336), amylase (U.S. Pat. No. 4,980,180), lactase (U.S. Pat. No. 4,323,651) and cyclo-malto-dextrin glucano-transferase (U.S. Pat. No. 5,102,800).
B. coagulans
has been used to produce lactic acid (U.S. Pat. No. 5,079,164). A strain of
B. coagulans
(referred to as
L. sporogenes
Sakaguti & Nakayama (ATCC 31284)) has been combined with other lactic acid producing bacteria and
B. natto
to produce a fermented food product from steamed soybeans (U.S. Pat. No. 4,110,477).
B. coagulans
strains have also been used as animal feeds additives for poultry and livestock to reduce disease and improve feed utilization and, therefore, to increase growth rate in the animals (International PCT Pat. Applications No. WO 9314187 and No. WO 9411492).
In particular,
B. coagulans
strains have been used to reduce serum cholesterol in certain formulations (Mohan et al,
Indian J. Medical Research,
92:431-432, 1990), although this approach did not reduce triglycerides sufficiently and resulted in excessive reductions on “good” cholesterol, e.g., high density lipoprotein (HDL).
Supplementation of diet with fructo-oligosaccharides (FOS) have been reported to provide health benefits including reduction of serum triglycerides. Mitsuoka et al,
Nutrition Research,
4:961-966, 1984.
However, there remains a need for control of cholesterol to treat cholesterol related diseases.
SUMMARY OF THE INVENTION
It has now been discovered that serum cholesterol can be controlled and reduced while maintaining or increasing HDL by use of a combination of active agents in a therapeutic composition that includes a non-pathogenic lactic acid producing bacteria, such as
Bacillus coagulans
, and a therapeutic agent selected from the group consisting of an effective amount of a cholesterol-reducing agent and a bifidogenic oligosaccharide.
According to a preferred embodiment of the invention, there is provided a composition comprising an isolated
Bacillus coagulans
strain in combination with an effective amount of a fructo-oligosaccharide (FOS) in a pharmaceutically acceptable carrier suitable for administration to the digestive track of a human. In one embodiment of the composition, the
Bacillus coagulans
strain is included in the composition in the form of spores. In another embodiment, the
Bacillus coagulans
strain is included in the composition in the form of a dried cell mass.
The invention also describes a method for decreasing serum cholesterol and increasing serum HDL in a patient comprising administering an effective amount of a composition comprising viable lactic acid-producing bacteria and a therapeutic agent selected from the group consisting of an effective amount of a cholesterol-reducing agent and a bifidogenic oligosaccharide. The composition may optionally include a cholic acid complexation agent such as a metal salt and the like.
The invention also describes a therapeutic system for reducing serum cholesterol comprising a container comprising a label and a composition as described herein, wherein said label comprises instructions for use of the composition for reduction of serum cholesterol.
It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
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Fukushima et al., “The effects of a probiotic on faecal and liver lipid classes in rats”, British Journal of Nutrition, 1995, vol. 73, No. 5, p. 701-710.*
Baker et al., “Growth Requirements of 94 Strains of Thermophilic Bacilli,” CA. J. Microbiol., 6:557-563, 1960.
Bergey's Manual of Systemic Bacteriology, vol. 2, Sneath, P.H.A. et al., eds., Williams & Wilkens, Baltimore, MD, 1986.
Elmer et al., “A Neglected Modality for the Treatment and Prevention of Selected Intestinal and Vaginal Infections,” JAMA, 275: 870-876, 1996.
Gorbach, “Lactic Acid Bacteria and Human Health,” Ann. Med., 22:37-41, 1990.
Lidbeck et al., “Lactobacillli, anticarcinogenic activities and human intestinal microflora,” Eur. J. Cancer Prev. 1:341-353, 1992.
Malin et al., “Promotion of IgA Immune Response in Patients with Crohn's Disease by Oral Bacteriotherapy withLactobacillusGG,” Ann. Nutr. Metab., 40:137-145,1996.
Mohan et al., “Preliminary Observations on Effect of Lactobacillus Sporogenes on Serum Lipid Levels in Hypercholesterolemin Patients,” The Indian Journal of Medical Research, 92; 431-432, 1990.
Molin et al., “Effect of Fermented Oatmeal Soup on te Cholesterol Level and Lactobacillus Colonization of Rat Intestinal Mucosa,” Antonie Van Leeuwenhoek, 61(3); 167-173, 1992.
Mitsuoka et al., “Effects of Fructo-oligosaccharides on Blood Glucose and Serum Lipids in Diabetic Subjects,” Nutrition Research, 4:961-966, 1984.
Nakamura et al., “Taxonomic Study ofBacillus coagululansHammer 1915 with a Proposal forBacillus smithiisp. nov.,” Int. J. Syst. Bacteriol., 38:63-73, 1988.
Perdigon et al., “Symposium: Probiotic Bacteria for Humans: Clinical Systems for Evaluation of Effectiveness,” J. Dairy Sci., 78:1597-1606, 1995.
Rafter et al., “The Role of Lactic Acid Bacteria in Colon Cancer Prevention,” Scand. J. Gastroenterol., 80:497-502, 1995.
Reid et al., “Is there a Role for Lactobacilli in Prevention of Urogenital and Intestinal Infections?” Clin. Microbiol. Rev., 335-344, 1990.
Salimen et a
Farmer Sean
Lefkowitz Andrew R.
Beattie Ingrid A.
Davis Ruth A.
Ganeden Biotech, Inc.
Lankford , Jr. Leon B.
Mintz Levin Cohn Ferris Glovsky and Popeo
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