Vaginal lactobacillus medicant

Details Vaginal lactobacillus medicant Vaginal lactobacillus medicant

2000-01-05

2002-04-16

Park, Hankyel T. (Department: 1648)

Drug, bio-affecting and body treating compositions

Whole live micro-organism, cell, or virus containing

Bacteria or actinomycetales

C435S243000, C435S252100, C435S252900

Reexamination Certificate

active

06372209

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a bacterium of the genus Lactobacillus with desirable characteristics suitable for use in a vaginal medicant. More particularly, this invention relates to a vaginal medicant having a substantially pure culture of preserved microbial cells, to a preservation matrix, to a method for preserving the microbial cells within the preservation matrix, and to methods for preventing and treating vaginal infections.
BACKGROUND OF THE INVENTION
Lower genital tract infections, including sexually transmitted diseases (STDs) are some of the most common clinical problems among women of childbearing age. Over 10 million office visits each year in the United States are attributed to vaginal complaints. Vaginal discharge can be due to vaginal infections (yeast, bacterial vaginosis and trichomonas) or cervical infections (gonorrhea or chlamydia). Additionally, there is a body of evidence linking vaginal infections to preterm delivery, low birth weight, and neonatal mortality, which are some of the most important problems faced in obstetrics. Bacterial vaginosis is one of the most common genital infections in pregnancy. Women with bacterial vaginosis diagnosed during the second trimester of pregnancy are 40 percent more likely to give birth to a premature, low-birth weight infant than women without bacterial vaginosis. The prevention of even a small proportion of such births could translate into large monetary savings and a decrease in neonatal morbidity and mortality.
Lactobacilli are gram positive rods that are a part of the microbial flora of the human gut, mouth, and vagina. Vaginal Lactobacilli are thought to play an important role in resistance to infection via production of lactic acid and acidification of the vagina or by production of other antimicrobial products, such as hydrogen peroxide H
2
O
2
. It has been demonstrated that women with predominant vaginal Lactobacillus flora have a 50% lower frequency of gonorrhea, chlamydial infections, trichomoniasis and bacterial vaginosis. The presence of H
2
O
2
-producing Lactobacilli in the vagina have been linked to a decreased frequency of bacterial vaginosis, symptomatic yeast vaginitis and sexually transmitted pathogens including
Neisseria gonorrhea, Chlamydia trachomatis
, and
Trichomonas vaginalis
. In vitro studies have demonstrated that H
2
O
2
-producing Lactobacilli have potent bactericidal and viricidal properties against vaginal pathogens and even against human immunodeficiency virus (HIV).
Unfortunately, many women of childbearing age lack vaginal Lactobacilli. The vaginal ecosystem is dynamically affected by medications, general health status, sexual practices and contraception. Many vaginal and systemic medications may kill vaginal Lactobacilli. Hence, treatment of sexually transmitted diseases with antibiotics may place women at increased risk for repeated acquisition of the diseases. These findings, along with the widespread belief that Lactobacilli generally promote vaginal health, have suggested to clinicians that women should recolonize the vagina with Lactobacillus to prevent or treat genital tract infections.
Lactobacillus products for intravaginal or oral use have been available for over 100 years in the form of “
acidophilus
” preparations available in health food stores, and
acidophilus
milk or yogurt bought in grocery stores (e.g., these products typically advertise the inclusion of a strain of
Lactobacillus acidophilus
). These products have included vaginal suppositories containing lyophilized
Lactobacillus acidophilus
of human origin as well as various nutritional supplements. These products have been largely non-efficacious due to the failure of the products to colonize the vagina with the exogenous Lactobacilli. These failures are likely due to the poor quality of the commercially available products. It has been documented that Lactobacillus products sold as part of foods or as Lactobacillus supplements are often contaminated with other potential pathogens. In addition, Lactobacillus obtained from yogurt has been shown to be unable to bind to vaginal epithelial cells. The binding of Lactobacilli to the epithelial cells is a necessary step to establish colonization of the host organism. Therefore, the use of commercially available Lactobacillus products is thought to have little utility in prevention or treatment of vaginal infection because the products contain inappropriate microbe strains (e.g., many contain strains which are rarely recovered from the vagina), are contaminated with other potentially pathogenic organisms, have low microbe viability, and/or the microbes typically do not have the ability to bind to vaginal epithelial cells and establish colonization.
Therefore, there is a need for a product for the treatment of vaginal infections which can be manufactured under exacting conditions and which uses appropriate human strains of Lactobacillus having in vivo microbicidal properties, active adherence and an effective potency of viable microbes.
SUMMARY OF THE INVENTION
The present invention generally relates to a bacterium of the genus Lactobacillus with desirable characteristics suitable for use in a vaginal medicant. More particularly, this invention relates to vaginal, rectal and oral medicants having a substantially pure culture of preserved microbial cells, to a preservation matrix and to methods for preventing and treating vaginal infections.
The unique strains of Lactobacillus disclosed herein, when administered in vivo, will colonize and remain affixed to vaginal epithelial cells. These unique strains can then be recovered from the vaginal milieu over time. Such sustained colonization and viability of the Lactobacillus strains is largely attributable to the novel preservation matrix disclosed herein. The protection afforded by the preservation matrix of the present invention allows the Lactobacillus strains to adhere to vaginal epithelial cells in a metabolically inactive state and retain placement while returning to an active state capable of producing functional inhibitory by-products. Such capabilities of a matrix for microbial cells has been heretofore unobserved. The preservation matrix of the present invention also provides the flexibility to allow various drying methods in the production of a commercial suppository product. One embodiment of the present invention relates to a vaginal medicant. Such a medicant includes a substantially pure bacterial culture of an isolated strain of the genus Lactobacillus having identifying characteristics which include (i) a percent vaginal epithelial cell (VEC) cohesion value (as defined below) of at least about 50% and (ii) an ability to produce greater than about 0.5 ppm of H
2
O
2
under effective culture conditions. The vaginal medicant of the present invention also includes a preservation matrix, which contains and preserves the bacterial culture. Such a matrix includes a biologically active binding agent, an antioxidant, a polyol, a carbohydrate and a proteinaceous material. In one embodiment, the matrix has a pH of from about 5.0 to about 7.0. In another embodiment, the matrix has a pH of about 7.0. The preservation matrix of the present invention is capable of maintaining at least about 10
6
viable, genetically stable cells for a period of at least about 12 months in vitro. In further embodiments, the matrix maintains at least about 10
7
viable cells for a period of at least about 12 months in vitro, and more preferably, at least about
10
8
viable cells for a period of at least about 12 months in vitro.
In other embodiments, the isolated Lactobacillus strain has a percent VEC cohesion value of at least about 65%, and more preferably, at least about 80% and even more preferably, at least about 95%. In still other embodiments, the isolated strain has an ability to produce at least about 10 ppm of H
2
O
2
, and more preferably, at least about 20 ppm of H
2
O
2
.
As mentioned above, one embodiment of the present invention relates to a strain of Lactobacillus as described above which adh

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