Use hydrolyzed medium containing microorganisms medicinally

Abstract

A method for treating a vaginal disease by applying a hydrolyzed product in a variety of ways including preferably intravaginal, as well as oral, rectal, or transcutaneous administration, inhalation, intravenous or intraperitoneal injection. The product is produced by providing at least one solid plant product reduced to small pieces and mixed with sugar and a biocompatible liquid for fermentation at a temperature of between 15 and 55 degrees C. until its acidity reaches the range of 300 to 900 Terner degrees. Alternatively, the product is prepared by mixing in predetermined amounts of sprouted grains, biocompatible liquid inoculated with at least one from a variety of non-pathogenic microorganisms, vegetables, fruits, berries, high protein products, herbs, sugar, and a chemical element such as potassium. The mixture is then fermented at a selected temperature for a specified length of time to reach high acidity and high concentration of products of bacterial metabolism. This invention relates to a hydrolyzed medium used for the prevention of and treatment for urogenital infections, cancer and endometriosis.

Description

CROSS-REFERENCE DATA [0001] This application is a continuation-in-part application by the same inventors of the U.S. patent application Ser. No. 11 / 057,776 filed Feb. 14, 2005 entitled “METHOD FOR TREATING A MEDICAL CONDITION WITH A HYDROLYZED MEDIUM CONTAINING MICROORGANISMS”, now abandoned, which in turn is a continuation-in-part of the U.S. patent application Ser. No. 10 / 178,447 filed Jun. 21, 2002 entitled “METHOD FOR PRODUCING A FERMENTED HYDROLYZED MEDIUM CONTAINING MICROORGANISMS”, now U.S. Pat. No. 6,953,574.FIELD OF THE INVENTION [0002] The present invention relates to a hydrolyzed medium made by fermentation with non-pathogenic microorganisms and to the process of manufacturing and use thereof for treatment of vaginal and other diseases. More particularly it relates to the production of sour milk based hydrolysate, which includes the fermentation of various food ingredients and plants using various non-pathogenic bacteria / yeast ingredients and some food-grade fungi in milk...

AI Technical Summary

Benefits of technology

[0025] It is another object of the invention to provide a fermented medium allowing the microorganisms to remain alive in active state so that better conditions are created for attachment thereof to the appropriate tissue of the host.

[0026] A further object of the present invention is to provide a medium of high acidity, at least above 3% of lactate concentration (>300 T0 or degrees Turner), to promote higher vitality of those microorganisms that survive in the process of natural selection in a harsh for them acidic environment. It is noted here that lactate also plays a role of a preservative for the medium of the invention.

[0031] A most beneficial application of probiotics according to the present invention is in woman health, because the normal vaginal microbiota is dominated by lactobacilli, especially Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus iners and Lactobacillus gasseri (Falagas et al. (2007) Clin. Microbiol. Infect., 13: 657-664). In fact, the vaginal microbial flora may play a role in maintaining human health (Sobel, (2000) Annu. Rev. Med., 51: 349-356; Cadieux et al. (2002) JAMA, 287:1940-1941). There is strong evidence that the absence of vaginal lactobacilli is associated with the development of bacterial vaginosis (Alvarez-Olmos et al., (2004) Am. Sex. Trans. Dis. Assoc., 31: 393-400). Lactobacillus species form a barrier population that protects the host from pathogen colonization by mechanisms that include adhesion to epithelial surfaces, self-aggregation and co-aggregation. There is much in vitro and in vivo data showing inhibition of vaginal pathogens by appropriate lactobacillus strains and by their cell-free culture supernatant (Burton (2003) Appl. Environ. Microbiol., 69:97-101; Reid et al. (2003) Nutraceut. Food, 8:145-148 and FEMS Immun. Med. Microbiol. 35: 131-134; Atassi et al. (2006) FEMS Immunol Med. Microbiol., 48: 424-432; Falagas et al. (2007) Clin. Microbiol. Infect., 13: 657-664; U.S. Pat. No. 6,479,051 by Bruce, et al.; U.S. Pat. No. 6,468,526 by Chrisope and many others). The mechanism(s) underlying the antagonistic activity of Lactobacillus strains appear to be multifaceted, and include the production of hydrogen peroxide, lactic acid, and antibacterial compounds including bacteriocins or bacteriocin-like molecules, non-bacteriocin molecules, and non-lactic acid molecules (Servin (2004) FEMS Microbiol. Rev., 28: 405-440). The production of lactic acid by lactobacilli is primarily responsible for the low vaginal pH (below 4.5) and is one of the important factors for the inhibition of the growth of uro-pathogens (Tomas et al., (2003) J. Med. Microbiol., 52, 1117-1124). It should be noted that the killing activity exerted by the compounds(s) present in culture supernatant of some probiotic strains is potentiated in acidic conditions (Atassi et al. (2006) FEMS Immunol Med. Microbiol., 48: 424-432). Nevertheless, for the majority of known selected probiotic Lactobacillus strains, the compound(s) exerting killing activity against uro-pathogenic, entero-virulent or vaginosis-associated bacterial pathogens have not been characterized (Servin, (2004) FEMS Microbiol. Rev., 28: 405-440). In actuality, the presence of lactobacilli does not necessarily exclude potential pathogens from the vagina, as there is a constant battle between friendly and pathogen bacteria there involving host defenses (Saunders et al. (2007) Colloids and Surfaces B: Biointerfaces 55 (2007) 138-142). Administration of lactobacilli and products of their metabolism shifts this equilibration forward to healthy state, i.e. lack of symptoms and signs of disease, and the regained dominance of lactobacilli. A frequent source of pathogens for urinary and vaginal tract infections in women is the intestinal tract (Sanders (2000) J Nutr., 130:384 S-390S). Therefore, oral administration of Lactobacilli may provide a therapeutic effect for such problems in women. However, intra-vaginal or oral plus intra-vaginal application is likely to be even more efficient.

[0034] The medium of the invention includes only food products, is not toxic and quite safe, and can be successfully utilized in high-risk patients, such as the elderly, hospitalized and the immunocompromised, including AIDS patients. No side effects were observed in babies or pregnant women in our studies.

[0035] The efficacy of the medium of the invention is comparable to modern pharmacological drugs (antibiotics, and antiviral and anti-fungal compounds). Moreover, this medium is shown to be effective against life-threatening diseases, such as cancer, tuberculosis, HIV / AIDS, pneumonia and others, where traditional pharmacological drugs failed. No drug interaction was observed between pharmacological drugs and the medium of the present invention. On the contrary, the medium reduced considerably the side effects caused by toxic pharmacological drugs.

Problems solved by technology

When fermentation stops prior to the complete conversion of sugar into alcohol or acids, a stuck fermentation is said to have occurred.

A stuck fermentation may be caused by: 1) insufficient or incomplete nutrients required for the yeast (bacteria) to complete fermentation, 2) low temperatures, or temperature changes, which cause the yeast (bacteria) to stop their activity prematurely; or 3) the percentage of alcohol (or fermented end products) has become too high for the particular yeast (bacteria) selected for the fermentation.

However, fermentation is not stopped at this temperature, it is only slowed down; therefore the shelf-life of yogurt with live lactic acid bacteria is less than one month.

It has been proposed that this is due to their producing an uncomfortable environment (production of large amounts of acids and other byproducts such as fatty acids and hydrogen peroxide).

It has been proven that probiotics interfere with the display of mutagenic and genotoxic effects in the colon (Gallaher and Khil, 1999; Reddy 1999), and in other organs (Taper and Roberfroid, 1999; Reddy and Rivenson, 1993).

E-coli is not exactly non-pathogenic and may cause some harm to humans in certain conditions.

Rather, evaporation and condensation is used which limits the end properties of the product.

Even with E-coli present, the antagonistic activity is limited because some pathogens can still grow in the medium during incubation for 24 hours.

Despite their health promoting effects, probiotics have only demonstrated short-term effects.

Moreover, the effects of probiotics in life-threatening diseases, such as cancer for example, are doubtful (Sanders (1999) J. Food Technol., 53:67-77).

In our opinion, this step effectively damages all useful ferments contained in the grass and significantly reduces its effectiveness.

Another limitation is the typical addition of sugar at the end of cultivation.

However, high acidity (above 800 T0) may be toxic to some extent.

One probable reason for limited effectiveness of probiotics in general is because of poor binding of the active microorganisms to the internal linings or external surface of the human body.

Bacteria, especially in the state of freeze-dried suspension, have only limited time to develop a bond with the host.

Therefore, the bacteria are frequently expelled by natural processes such as digestion without allowing it to bond to the intestines and to produce enzymes, vitamins, amino acids, organic acids and other products of their metabolism.