Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
2000-06-20
2003-03-25
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S093100, C424S093300, C424S093400
Reexamination Certificate
active
06537544
ABSTRACT:
The present invention refers to new strains of the genus Lactobacillus, and an equine feed product comprising one or more of said strains.
BACKGROUND OF THE INVENTION
Disturbances in the equine intestinal flora can bring about a deteriorated ability to take up the nutriment from the feed, a reduced efficiency, a deteriorated resistance to infections and accompanying infections of different kinds. Other symptoms are a changed consistency of the excrements, which are often malodorous, and an ugly coat of hair. It is well known that disturbances of the intestinal flora above all appear in stress situations, for instance during long transportations or change of stable environment, too tough training and change of feed, but also in treatment with antibiotics. Problems of a disturbed intestinal flora also occur in foals, which during their first living have to obtain an intestinal microflora of their own.
Different disorders which can be associated with a change of the intestinal bacterial flora are inflammations in the intestinal mucosa and gastric ulcer, and bacterial infections giving for instance acute colitis, such as intestinal chlostridiosis, manifesting in diarrhea and toxemia and caused by i.a.
Clostridium difficile
, and colic, such as Baron-Gruff-disease, which is caused by
Clostridium perfringens.
The presence of coliform bacteria in the excrements has since long been used to judge the state of health in horses as to disturbances of the intestinal flora. A high content of said bacteria has been considered to indicate that the intestines are in good condition, while a low content thereof, as well as a high content of Bacillus and Clostridium spp, respectively, have been associated with intestinal disturbances. The presence of moulds and other fungus also have been considered to have an injurious effect on the intestinal flora. In addition a reduced body temperature, lower than 37° C., has been considered to indicate problems in the gastrointestinal tract. The normal temperature in horses is within the range 37.3-37.8° C.
Lactobacilli is one of the main groups of microorganisms in the intestinal microflora of healthy horses. Fujisawa et al. discloses in Bifidobacteria Microflora, Vol. 12(2), p. 87-90, 1993, the isolation of 286 strains of lactobacilli from the gastrointestinal tract of healthy horses. The main part of the strains could be identified as belonging to the species
L. salivarius, L. acidophilus
and
L. reuteri
and the last two species were found in all parts of the gastrointestinal tract while
L. salivarius
was not isolated from the stomach. It is also important to remember that the microflora is also influenced by the type of feed that the horse eats.
Probiotics, that is different bacterial and yeast preparations which are orally administrated with the purpose to improve the health in man and animals, have since long been used against intestinal disturbances to improve the intestinal function and the general state of health. As probiotics are commonly used different strains of lactic acid producing bacteria, such as strains of Lactobacillus and Streptococcus. The probiotic hypotesis says that if said bacteria can be added to the intestines in a sufficient amount during conditions of stress or illness, that is when the intestinal flora is disturbed in such a way that pathogenic bacteria are favoured, an establishment of the not wanted bacterial strains in the intestines will be counteracted. To maintain a healthy intestinal flora would then be decisive to prevent those disorders which are associated with a disturbance of the intestinal flora.
In Fox, Veterinary Medicine, August 1988, Probiotics: Intestinal inoculants for production animals, a review is made of different commercial probiotics used in raising different animals, especially chickens, pigs and calves.
PRIOR ART
It is today common to feed horses having malodorous excrements with sour milk or yoghurt to overcome the underlying disturbances in the stomach and intestines. Equine products on the market are for instance Bakteriebalans (Lantmännen, Sweden) and Lactosat® häst (Ewos Sverige AB, Södertälje) which both contain three different strains of lactic acid producing bacteria, that is of
Lactobacillus bulgaricus, Streptococcus thermophilus
and
Streptococcus faecium
. Said agents have in common that the lactobacilli which are present in the administrated products either are such which are naturally prevailing in the fermented product or such which have been isolated from man.
Another agent which has been used against equine intestinal disturbances is ColiCure (VETTECH AB, Stockholm), a product consisting of a purified and stabilized strain of
Eschericia coli
, which was originally isolated from horse, in a concentration of >10
9
viable bacteria/ml. The same principle is behind the administration of “mash”, that is dispersed excrements from a healthy horse, that is to get a bacterial strain which fits into the intestinal environment and can become established therein. It is, however, controversial to add bacteria of the family Enterobacteriaceae, for instance
E. coli
, in view of pathogenicity and occurrence of endotoxines.
EP 0 203 586 discloses a composition for treatment of gastrointestinal disorders in animals, especially those being caused by enterotoxigenic strains of
Escherichia coli
, which is based on the strain
Lactobacillus fermentum
ATCC 53113, which has been isolated from pig. An advantage of the new composition is said to be that it is not pathogenic and acts by preventing infectious organisms from binding to the intestinal mucosa. An overview is also given of different bacteria which have been used to prevent or to remedy gastro-intestinal disorders, but which have all turned out to be effective only in part.
It has previously been shown that certain strains of
Lactobacillus plantarum
have the ability for a certain period of time to become established in the intestinal system of man. In EP 92916294.9 certain strains of Lactobacillus, especially
L. plantarum
299 DSM 6595 and variants thereof having the ability to become established in the intestines and to remain for at least 11 days after oral administration, are described. Said strains have turned out to have a favourable effect on different disturbances of the intestinal microflora in man.
The normal lactobacilli flora in the intestines of different animal species are different and although the same species of Lactobacillus can be found in two different animal species, the bacteria do not normally belong to the same strain of said species. The strains present differences between themselves which are of importance for their chances of becoming established in the actual environment. In order to be able to treat gastrointestinal disorders in horses, there is therefore a continous need of a safe, non-toxic product comprising one or more bacterial strains having the ability to become established in the equine intestines.
DESCRIPTION OF THE INVENTION
The invention refers to an equine feed product preventing and rectifying microbially caused intestinal disturbances, which contains one or more strains of Lactobacillus which have been isolated from the gastric or intestinal mucosa of horse and which have the ability to colonize in the equine intestines.
Horse refers in this connection to subjects of the genus Equidae, that is in addition to horse also donkey and zebra, having a similar composition of the intestinal flora.
The feed product according to the invention is preferably a feed which has been fermented with a strain of Lactobacillus which has been isolated from the gastric or intestinal mucosa of horse and which has the ability to colonize in the equine intestines.
The feed product according to the invention is preferably based on a cereal based grain or supplementary feed, green forage or hay.
A preferred aspect of the invention is a feed product based on oats which has been fermented with one or more strains of lactobacilli isolated from horse, especially with any of the new strains stated below.
According to an
Johansson Marie-Louise
Lönner Clas
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
Probi AB
Witz Jean C.
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