Chemistry: molecular biology and microbiology – Micro-organism – per se ; compositions thereof; proces of...
Reexamination Certificate
2000-07-21
2001-07-17
Lankford, Jr., Leon B. (Department: 1651)
Chemistry: molecular biology and microbiology
Micro-organism, per se ; compositions thereof; proces of...
C435S004000, C435S007320, C435S029000, C435S034000, C435S252100
Reexamination Certificate
active
06261824
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an isolated bacterium and uses of the bacterium to diagnose gastrointestinal diseases caused by the bacterium.
BACKGROUND ART
Gastrointestinal disease is a common affliction in animals and humans. Although many aetiological agents including viruses, bacteria and protozoa, have been recognised to cause this disease, there are still many clinical cases from which no causative agent can be identified. Furthermore, many cases do not respond to standard medical treatment regimes suggesting that some unknown agent or agents may be involved.
There have been several new microorganisms identified recently that have been shown to cause gastrointestinal disease in animals including humans. In 1984, Marshall and Warren (Lancet 1984: 1312-1314) described Campylobacter-like, spiral. Gram negative bacteria 2.5 &mgr;m in length and 0.5 &mgr;m in diameter in patients with gastritis and peptic ulcers, now known as
Helicobacter pylori.
In 1987, Dent et al (Lancet 1987 ii:96) reported a new Gram negative spiral bacterium, 3.5-7.5 &mgr;m in length and 0.9 &mgr;m in diameter in patients with gastritis and named it as
Gastrospirillum hominis.
This organism is now called
Helicobacter helimanii.
The present inventor has isolated and identified a new bacterium that is implicated in gastrointestinal disease in humans.
DISCLOSURE OF INVENTION
A new coccoid form of bacterium, distinct from the coccoid form of
Helicobacter pylori,
which can colonise the human stomach was identified and isolated from a patient with dyspeptic symptoms and found to suffer from a diffused gastritis associated with an erosive gastroduodenitis and multiple superficial ulcerations. The bacterium was resistant to usual triple antibiotic therapy composed of tetracycline, metronidazole, and an H
2
antagonist. Symptomatic remission and histological and electron microscopic resolution of the gastro-duodenalpathology following a proton pump inhibitor suggests possible role in the pathogenesis of erosive gastro-duodenitis and multiple superficial ulcerations. The organism is coccoid form and varying in size 0.2-0.75 &mgr;m in diameter, most being 0.3-0.5 &mgr;m in diameter, with outer membrane pilli. The bacterium has been named by the present inventors as
Okadaella gastrococcus
Gen. nov, Sp. nov.
In a first aspect, the present invention consists in an isolated bacterium capable of causing gastrointestinal disease in an animal and having the characteristics of
Okadaella gastrococcus
as herein defined.
Preferably, the bacterium has the following characteristics:
Gram negative;
coccoid;
culturable under microaerophilic and anaerobic conditions;
urease-negative under culture for 2 weeks;
catalase-negative;
oxidase-negative;
contains flagella and may contain microfilamentous hair-like pilli;
bacterial colonies do not fluoresce under ultraviolet light (360 nm);
colonies observed as numerous round “dots” in the Warthin-Starry silver strain; and
non
Helicobacter pylori
and non
Helicobacter helimanii.
A sample of
Okadaella gastrococcus
was deposited under the provisions of the Budapest Treaty with the Australian Government Analytical Laboratories (AGAL) on Sep. 22, 1998 and given Accession Number NM 98/08610.
In a second aspect, the present invention consists in a method of diagnosing gastrointestinal disease in an animal caused by
Okadaella gastrococcus,
the method comprising identifying the presence of the bacterium according to the first aspect of the present invention in the gastrointestinal tract of, or a clinical specimen from, the animal.
The bacterium may be detected directly by culturing the bacterium from a clinical specimen, identifying the bacterium by microscopy, or may be identified indirectly by the use of antibodies to the bacterium. The clinical specimen may be a biopsy, stool specimen, blood sample, or the like. It will be appreciated that the discovery of the bacterium and its association with gastrointestinal disease will allow its detection by any of the known methods of the art. It will also be appreciated that molecular detection methods like polymerase chain reaction (PCR) can also be used to identify the presence of the bacterium in a clinical specimen.
The presence of the bacterium in an animal that does not have clinical signs of gastrointestinal disease may also be indicative of pre-disposition of that animal to gastrointestinal disease. Therefore, the scope of the second aspect of the present invention also includes screening for the presence of the bacterium in animals as a means of detecting animals that may be susceptible to gastrointestinal disease caused by this bacterium.
Preferably, the animal is a human.
In a third aspect, the present invention consists in use of the bacterium according to the first aspect of the present invention to develop diagnostic tools or aids for the detection or diagnosis of disease caused by the bacterium. Such diagnostic tools or aids include molecular probes devised from the genome of the bacterium and antibodies.
Throughout this specification, unless the context requires otherwise, the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers, or steps.
REFERENCES:
patent: 5464755 (1995-11-01), Bochner
International Search Report for PCT/AU98/00791 dated Oct. 20, 1998.
International Preliminary Examination Report for PCT/AU98/00791 dated Jul. 26, 1999.
“Gram-Negative Aerobic/Microaerophilic Rods and Cocci”, Bergey's Manual of Derteminative Bacteriology-9, pp. 71-102.
“Anaerobic Gram-Negative Cocci”, Bergey's Manual of Determinative Bacteriology-9, pp. 347-348.
Lankford , Jr. Leon B.
Marshall O'Toole Gerstein Murray & Borun
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