Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-01-29
2002-02-19
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S093400
Reexamination Certificate
active
06348452
ABSTRACT:
TECHNICAL FIELD
This invention relates to methods of enhancing resident populations of microorganisms or suppressing undesirable populations of microorganisms at selected sites of the gastrointestinal tract of animals including humans. As used in this specification, probiotic or probiotic microorganism is a live microbial feed supplement which beneficially affects the host animal by improving its intestinal microbial balance. This is the definition provided by R. Fuller (AFRC Institute of Food Research, Reading Laboratory, UK) in—Journal of Applied Bacteriology, 1989. 66, pp.365-378. “Probiotics in Man and Animals—A Review”, and has subsequently been extended to include supplements and food for humans.
BACKGROUND ART
The gastrointestinal tract microflora of the healthy subject protects the host from pathogen invasion. In the young, the elderly and the compromised patient, however, this protective barrier is less effective. An individual can be compromised to various degrees ranging from minor stress and related events, for example, dietary changes, emotional and nutritional stresses, to extreme cases such as in immuno-compromised patients and patients undergoing radio- and chemotherapy.
Probiotic bacteria have been described to exert antimicrobial effects which refers to the actions of the probiotic preparation on another microbe or group of microbes in the gastrointestinal tract. These are directly applicable to the use of probiotics for enhanced resistance against intestinal pathogens, prevention of diarrhoea and constipation. The types of interactions include competitive colonisation as well as adhesion and growth inhibition.
Competitive colonisation refers to the fact that the probiotic strain can successfully out-compete the pathogen for either nutrients or the site of colonisation. Since many gastrointestinal pathogens attach to the intestinal mucosa as the first step in infection, it would be beneficial to the host if this adhesion could be inhibited. There are reports that lactobacilli produce components which inhibit attachment of enterotoxigenic
Escherichia coli
to intestinal mucosa. In addition, various compounds produced during growth of the probiotic have been shown to inhibit pathogen growth. These include organic acids such as lactic and acetic acid, reuterin and bacteriocins. Organic acids lower the pH and thereby can indirectly affect growth of the pathogen. In addition, the lactic and acetic acids can be toxic to microbes. Reuterin which inhibits the growth of a very broad range of cells is produced by
Lactobacillus reuteri
when grown in the presence of glycerol. Numerous bacteriocins have been reported to be produced by lactobacilli e.g. Acidophilin, Acidolin, Lactocidin, Bacteriocin, Bulgarican, Lactolin, Lactobacillin and Lactobrevin. They can either have a very broad range of activity or alternatively specifically inhibit the growth of a very limited range of closely related microbes. For example, Lactobacillus sp can exhibit specific antagonistic effects towards
Clostridium ramnosum.
There are different levels of specific bacterial populations in the various regions of the gastrointestinal tract of humans and animals. In addition, it has been shown that the specific strains of the various genera and species vary from one region of the digestive tract to another. It has been shown that dietary fibre influences microbial activity and gas production in the various regions of the gastrointestinal tract of pigs.
In humans it is known that the major carbohydrate sources for bacterial growth in the colon are provided by dietary and endogenous means and that bacteria in the proximal colon have a relatively high supply of dietary nutrients and grow at a fast rate causing a decrease in nutrients available in the distal region resulting in bacteria growing more slowly and the pH frequently approaches neutrality. Because of these varying physiochemical conditions, gross metabolic differences are likely to occur between bacteria resident in the right or left sides of the colon. There is a correlation between the fast and slow rate of bacterial growth in the proximal and distal colon, respectively, with the incidence of disease, including cancer. In the region of fast growth, there is a lower incidence of disease than in the distal colon.
It is the contention of many scientists that the health and well being of people can be positively or negatively influenced by the microorganisms which inhabit the gastrointestinal tract, and in particular, the large bowel. These microorganisms through the production of toxins, metabolic by-products, short chain fatty acids, and the like affect the physiological condition of the host.
The constitution and quantity of the gut microflora can be influenced by conditions or stress induced by disease, life style, travel, and other factors. If microorganisms which positively affect the health and well being of the individual can be encouraged to populate the large bowel, this should improve the physiological well being of the host.
The introduction of beneficial microorganisms, or probiotics, is normally accomplished by the ingestion of the organisms in drinks, yoghurts, capsules, and other forms in such a way that the organism arrives in a viable condition in the large bowel.
It has been demonstrated by Englyst H. N. et al (1987) “Polysaccharides breakdown by mixed populations of human faecal bacteria”, FEMS Microbiology Ecol 95: 163-71, that the bacterial fermentation of resistant starch in the large bowel produces elevated levels of short chain fatty acids, particularly beneficial types such as propionate and butyrate.
The present inventors have realised that it would be desirable to not only deliver probiotic microorganisms to the large bowel but also to provide a medium that would function to promote the growth of the microorganisms when they reach the large bowel.
Surprisingly, it has been found that modified or unmodified resistant starches may function both as a means to transport the probiotic microorganisms to the large bowel and as a growth medium for the microorganism delivered to the target region of the large bowel. It has also been shown in International publication number WO 96/08261, the content of which is incorporated into this specification for the purposes of convenient cross-reference, that resistant starch may be eroded or pitted to afford protection of the associated probiotic microorganisms and that the microorganisms may also adhere to these starch granules. There is a need, however, to be able to deliver probiotics in a more efficient and economical manner.
It would also be desirable to be able to deliver substrate to specific sites of the gastrointestinal tract so as to either enhance or suppress the growth of particular populations of microorganisms at those sites without substantially affecting the populations of other microorganisms at other sites. The present inventors have developed improved methods for altering or influencing microbial populations of the gastrointestinal tract of animals including humans.
DISCLOSURE OF INVENTION
In a first aspect, the present invention consists in a method of enhancing a resident population of microorganism in a selected site of the gastrointestinal tract of an animal, the method comprising providing to the animal a selected modified or unmodified resistant starch or mixtures thereof in combination with one or more probiotic microorganisms such that upon ingestion the starch passes through the gastrointestinal tract substantially unutilized until it reaches the selected site where it is utilised by the resident and/or the probiotic microorganisms thereof causing an increase in number and/or activity of the microorganisms.
In a second aspect, the present invention consists in a method of suppressing an undesired resident population of microorganism in a selected site of the gastrointestinal tract of an animal, the method comprising providing to the animal a modified or unmodified resistant starch or mixtures thereof in combination with one or more probiotic microorga
Brown Ian L.
Conway Patricia Lynne
Evans Anthony John
Henriksson Karl Anders Olof
McNaught Kenneth J.
McDermott & Will & Emery
The University of New South Wales
Weddington Kevin E.
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