Lactobacillus and skim milk compositions and methods for prevent

Details Lactobacillus and skim milk compositions and methods for prevent Lactobacillus and skim milk compositions and methods for prevent

1994-09-19

1997-07-08

Wityshyn, Michael G.

Drug, bio-affecting and body treating compositions

Whole live micro-organism, cell, or virus containing

Bacteria or actinomycetales

424430, 424535, 514968, 4352529, 435853, 435854, 435855, 435856, 435857, A61K 3520, C12N 120

Patent

active

056458304

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

This invention relates to compositions and methods employing said compositions for preventing urogenital tract infections.


BACKGROUND TO THE INVENTION

It is well known that indigenous, non-pathogenic bacteria predominate on intestinal, vaginal and uro-epithelial cells and associated mucus in the healthy state, and that pathogenic organisms (such as bacteria, yeast, viruses) predominate in the stages leading to and during infections. Organisms such as Escherichia coli, enterococci, candida, Gardnerella and Klebsiella originate from the bowel, colonize the perineum, vagina, urethra and can infect the bladder and vagina. Treatment with antimicrobial agents is required to eradicate the organisms. However, infections can and do recur, for the urinary tract in an estimated 80% of cases. Prolonged use of antimicrobial agents creates drug resistant pathogens, breakthrough infections and a disruption of the normal flora. The possibility that indigenous bacteria have a role in preventing infection has been postulated for many years, but few studies have been carried out to identify specific bacteria and their properties required for such an effect. U.S. Pat. No. 4,314,995 to Hata et al. investigated anaerobic, lactobacilli-like organisms as a means of treating a number of infectious diseases, but no consideration was given to the combined importance of their hydrophobicity, hydrophillicity, adhesiveness to biomaterials, epithelial cells, mucus and tissues, and no discussion was included to prevent urogenital infections. U.S. Pat. No. 4,347,240 to Mutai et al. discloses a composition and method employing a specific strain of lactobacilli to inhibit tumour growth.
In recent years, our group has investigated the use of lactobacillus to prevent recurrent urinary tract infections, particularly in adult women. Our conclusion has been that the ability of lactobacilli to adhere, inhibit, competitively exclude and coaggregate formed the basis for the protection of the host. However, new and more important information has now come to light, further to human and experimental studies. The invention now takes into account a new infectious state (post-antimicrobial urogenital infections) as distinct from simple urinary tract infection. The former is initiated following use of antimicrobial agents. This application was not obvious previously, as previous literature has concentrated on virulence characteristics of pathogens causing problems, ignoring the fact that recurrences can follow the use of external agents. We previously recognized resistance to NONOXYNOL-9.RTM. as being important for selection of lactobacillus. However, the usage of this agent is not universal, and just because a strain can resist its action does not infer that it offers every lactobacillus strain the crucial component of protecting the host.
The ability of lactobacillus to produce inhibitory substances has been believed by us to be important. One obvious such product would be hydrogen peroxide. However, based upon our latest findings, this property is present in strains that do and those that do not protect women from reinfection. Thus, inhibitory activity is not the primary mechanism for prevention of infection.
The adherence of lactobacillus to epithelial cells has been regarded as important in the context of blocking access of pathogens to surfaces. However, what was not recognized previously was the hydrophobic and hydrophillic properties of these strains and the production of proteinaceous adhesions into the environment (supernatant). These new findings were not obvious and in fact describe totally new methods whereby lactobacilli colonize biomaterial and human cell surfaces. The use of intestinal cell monolayers has provided a system more closely related to the in vivo situation, showing that colonization of the intestine (to compete with uropathogenic organisms before they emerge to colonize the urogenital tract and infect the bladder and vagina) must reach higher levels (10 to 165 lactobacillus per cell) to achieve potent

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