Topical use of probiotic bacillus spores to prevent or control microbial infections
It has now been discovered that Bacillus species possess the ability to exhibit probiotic activity in aerobic conditions such as on skin or mucous membrane tissues and thereby treat, control and/or inhibit numerous conditions caused by microbial infections.
The invention describes therapeutic compositions, articles of manufacture and methods of use for inhibiting various microbial infections caused by bacteria, yeast, fungus or virus, which utilize isolated Bacillus species.
There are several Bacillus species useful according to the present invention, including Bacillus coagulans, Bacillus subtilis, Bacillus laterosporus and Bacillus laevolacticus. Although exemplary of the invention, Bacillus coagulans is only a model for the other Bacillus species, and therefore the invention is not to be considered as limiting.
According to the invention, there is provided a composition comprising an isolated Bacillus species in a pharmaceutically acceptable carrier suitable for topical application to skin or a mucous membrane of a mammal. In one embodiment of the composition, the Bacillus species is included in the composition in the form of spores. In another embodiment, the Bacillus species is included in the composition in the form of a dried cell mass. In the composition, the carrier may be an emulsion, cream, lotion, gel, oil, ointment, suspension, aerosol spray, powder, aerosol powder or semi-solid formulation.
According to a preferred aspect of the invention, there is provided a composition comprising an extracellular product of a Bacillus coagulans species in a pharmaceutically acceptable carrier suitable for topical application to skin or a mucous membrane of a mammal. In one embodiment, the extracellular product is a supernatant or filtrate of a culture of an isolated Bacillus coagulans species. The carrier may be an emulsion, cream, lotion, gel, oil, ointment, suspension, aerosol spray, powder, aerosol powder or semi-solid formulation.
According to another aspect of the invention, there is provided a method of preventing bacterial, yeast, fungal or viral infection including the steps of applying topically to skin or a mucous membrane of a mammal a probiotic composition comprising an isolated Bacillus species; and allowing the Bacillus species to grow topically for sufficient time to inhibit growth of bacteria, yeast, fungus or virus. One embodiment further includes the steps of providing spores of the Bacillus species in the probiotic composition, and allowing the spores to germinate after the applying step. In one embodiment, the step of allowing the Bacillus species to grow inhibits growth of one or more microbe species selected from the group consisting of Staphylococcus species, Streptococcus species, Pseudomonas species, Escherichia coli, Gardnere/la vagina/is, Propionibacterium acnes, Aeromonas hydrophilia, Aspergillus species, Proteus species, Aeromonas species, Clostridium species, Klebsiella species, Candida species and Trichophyton species. Also inhibited are certain virus species. In another embodiment, the applying step is applying a probiotic composition in the form of a cream, lotion, gel, oil, ointment, suspension, aerosol spray, powder, aerosol powder or semi-solid formulation.
According to another aspect of the invention, there is provided a method of inhibiting growth of bacteria, yeast, fungus, virus or a combination thereof, including the steps of applying topically to skin or a mucous membrane a composition comprising an extracellular product of an isolated Bacillus coagulans species, and allowing the composition to be present for sufficient time to inhibit growth of bacteria, yeast, fungus, virus or any combination thereof In one embodiment, the applying step includes applying the composition in the form of a cream, lotion, gel, oil, ointment, suspension, aerosol spray, powder, aerosol powder or semi-solid formulation.
According to another aspect of the invention, there is provided a composition comprising an isolated Bacillus species applied to a flexible article that is intended to be worn by or attached to skin or a mucous membrane of a mammal to allow probiotic activity of the isolated Bacillus species to occur adjacent to or on the skin or mucous membrane.
According to another aspect of the invention, there is provided a method of inhibiting growth of bacteria, yeast, fungus, virus or any combination thereof, including the steps of applying a composition comprising an isolated Bacillus species to a solid surface, contacting the solid surface with the applied Bacillus species thereon to skin or a mucous membrane of a mammal, and allowing the solid surface to contact the skin or mucous membrane for sufficient time to allow initiation of probiotic activity of the isolated Bacillus species to inhibit growth of bacteria, yeast, fungus, virus or a combination thereof adjacent to or on the skin or mucous membrane. In one embodiment, the applying step includes applying the composition to a diaper, pliable material for wiping skin or a mucous membrane, dermal patch, adhesive tape, absorbent pad, tampon or article of clothing. In another embodiment, the applying step includes impregnating the composition into a fibrous or nonfibrous solid matrix.
Summary of the Invention
The invention also describes a therapeutic system for treating, reducing or controlling microbial infections comprising a container comprising a label and a therapeutic composition as described herein, wherein said label comprises instructions for use of the composition for treating infection.
The invention provides several advantages. In particular, insofar as there is a detrimental effect to the use of antibiotics because of the potential to produce antibioticresistant microbial species, it is desirable to have an antimicrobial therapy which does not utilize conventional antimicrobial reagents. The present invention does not contribute to the production of future generation of antibiotic resistant pathogens.