Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Intentional mixture of two or more micro-organisms – cells,...
Reexamination Certificate
1998-06-26
2001-04-10
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Intentional mixture of two or more micro-organisms, cells,...
C424S093400, C424S093450
Reexamination Certificate
active
06214335
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a bacterial culture prepared from the intestinal tract of pathogen-free mammalian animals. It also relates to subcultures of such cultures and to methods of using the subcultures to protect livestock from colonization by enteropathogenic bacteria.
2. Description of the Related Art
Enteropathogens, such as Salmonella and
Escherichia coli
0157:H7, cause an unacceptably high incidence of morbidity and mortality in humans and may reduce productivity in livestock populations. Gastrointestinal pathogens in humans are typically derived from intestinal contamination of meats that humans consume. At a symposium on
Tracking Foodborne Pathogens from Farm to Table: Data Needs to Evaluate Control Groups
held in January, 1995, a question asked was “How important are foodborne diseases?” (Tracking Foodborne Pathogens from Farm to Table: Data Needs to Evaluate Control Groups, Washington, D.C., 3-29, 1995). It was stated that in the United States, there are an estimated 6.5 million to 33 million cases of foodborne diseases each year, resulting in up to 9,000 deaths. The USDA Economic Research Service estimates U.S. medical costs and productivity losses for seven foodborne pathogens at $5.6 billion to $9.4 billion annually. Menning estimates that there are over 5 million cases of meat and poultry foodborne diseases in the United States per year and a large percentage is attributable to Salmonella and Campylobacter infections (
J. Am. Vet. Med. Assoc
., Volume 192, 494-497, 1988). Roberts estimates that each case of salmonellosis costs $700 (
Amer. J. Agr. Econ
., Volume 71, 468-474, 1989). Based on surveys estimating foodborne disease in other countries, it would not be unreasonable to project that the number of worldwide foodborne diarrheas per year attributable to Salmonella probably exceeds 100 billion with an estimated cost exceeding 25 billion dollars. These pathogens also account for pain, suffering and loss of life. In addition, enteropathogenic bacteria may also cause substantial economic loss through infection of livestock.
Competitive exclusion (CE) techniques are used for decreasing colonization of enteropathogenic bacteria in poultry. Nurmi et al (
Nature
, Volume 241, 210-211 1973) found that preparations from mature, healthy chickens conferred protection to young chicks, whose microflora had not yet been established, against Salmonella colonization. Administration of undefined CE preparations to chicks speeds the maturation of gut flora in newly-hatched birds and provides a substrate for the natural process of transmission of microflora from the adult hen to its offspring.
Snoeyenbos et al (U.S. Pat. No. 4,335,107, June, 1982) developed a CE micorflora technique for preventing Salmonella colonization by lyophilizing fecal droppings and culturing this preparation anaerobically. Mikola et al (U.S. Pat. No. 4,657,762, April, 1987) used intestinal fecal and cecal contents as a source of CE microflora for preventing Salmonella colonization. Treatment with this type of culture required media to be anaerobic and pH balanced.
Stern et al (U.S. Pat. No. 5,451,400, Sep. 19, 1995) discloses a mucosal CE composition for protection of poultry against colonization by Salmonella and Campylobactor where the mucin layer of prewashed ceca is scraped and the scrapings, kept in an oxygen-free environment, are cultured anaerobically.
Nisbet et al (U.S. Pat. No. 5,478,557; Dec. 26, 1996) disclose a probiotic that can be obtained from a variety of domestic animals, including but not limited to fowl and also equine, porcine and bovine. Nisbet et al disclose that a stable defined probiotic is preferably obtained by continuous culture of a batch culture produced directly from fecal droppings, cecal and/or large intestine contents of the adult target animal. They further disclose that large quantities of the probiotic may be produced by either batch or continuous culture wherein the batch culture is continued until the concentration of acetic acid is greater than or equal to about 20 mM, the concentration of proprionic acid is greater than or equal to about 10 mM and the concentration of butyric plus isobutyric acid is greater than or equal to 15 mM.
Asplund et al (
Journal of Applied Bacteriology
, Volume 81, 217-223, 1996) report an in vitro model of the procine intestine and its use to show inhibiiton of
Yersinia enterocolitica
O:3 by pig ileal and caecal microflora. Caeca and distil parts of the small intestine are collected, kept under anaerobic conditions and the contents collected, pooled and cultivated. Caecal and ileal inocula are shown to suppress the growth of cultured
Y. enterolitica,
with caecal flora somewhat more effective than ileal flora. No in vivo efficacy was reported.
The present invention provides for the first time a composition and a method for reducing in vivo and/or preventing colonization of mammals, especially livestock, by enteropathogenic bacteria.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide an animal mucosal derived subculture for the control of enteropathogenic bacteria colonization of animals.
It is another object of the present invention to provide a method for treating animals to control enteropathogenic bacterial colonization of animals by using a preparation derived from a mucosal culture.
Further objects and advantages will become apparent from the following description.
DETAILED DESCRIPTION OF THE INVENTION
The importance of enteric infections in humans has been increasingly well recognized over the last dozen years. The relationship of livestock contamination and human infection has, likewise, become well documented. During production and processing of animals, such as livestock, fecal material containing pathogens may be transferred onto meat and persist into food processing kitchens. Swine, along with poultry, cattle and seafood, are important carriers of Salmonella (
Bean et al, J. Food Protect
., Volume 53, 804-817, 1990; Lammerding et al
J. Food Protect
., Volume 51, 47-52, 1988). Naive animals are infected from contaminated feed, chronic carriers which are introduced into the population, infected rodents, or from contaminated farm personnel (Heard,
Vet. Rec
., Volume 85, 482-484, 1969; Williams et at,
J. Hyg. Camb
., Volume 66, 281-293, 1968; Wilcock et al,
Diseases in Swine,
Leman et al, eds., Iowa State University Press, Ames, Iowa, 570-583, 1992; Duhamel et al, Proc. 12th Int. Symp. New and Emerging Infect. Dis., San Diego, Calif., 381, 1992). For swine, at the abattoir, the initial source of contamination is the carrier pig, and transmission is thought to occur by pig-to-pig contact or from exposure to the contaminated physical environment (Newell et al,
J. Am. Vet. Med. Assoc
., Volume 158, 89-98, 1971). These infected animals, in turn, contaminate the premises, equipment, and personnel leading to contamination of the final product (Williams et al, Am.
J. Pub. Health
, Volume 60, 926-929, 1970; Newel et al, supra; Morgan et al,
Epidemiol. Infect
., Volume 98, 323-330, 1987). The initial source, however, remains the carrier pig. Current efforts to identify and eradicate the carrier population in livestock has been impeded by a lack of information regarding the epidemiology and pathogenesis of salmonellosis in livestock. Because Salmonella species are widely distributed and persist well in the environment, elimination and control has been difficult. There is substantial amount of information regarding the virulence of Salmonella relevant to the pathogenesis in man. However, very little information is available regarding animal sources of this infectious agent. An understanding of the infectious process in food producing animal sources has assumed greater priority and control and elimination of the carrier animal will prevent zoonotic transmission of the disease. The control of food-borne disease can be best obtained through identification and eradication of the carrier population. While the carrier state may occur a
Bailey J. Stan
Cox Nelson A.
Cray Paula J.
Stern Norman J.
Fado John D.
Poulos Gail E.
Silverstein M. Howard
The United States of America as represented by the Secretary of
Witz Jean C.
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