Title:  Food for inhibiting infection and treating gastritis, gastric and duodenal ulcers

United States Patent:  6,329,002

Appl. No.:  498668

Foreign Application Priority Data:  Feb 08, 1999[KR] (99-4234);  Sep 20, 1999[KR] (99-40387)

Live strains of Lactococcus sp. HY 49, Lactobacillus casei HY 2782, and Bifidobacterium longum HY 8001 maintained in nutritious foods, such as yogurt, imbue them with prophylactic and/or therapeutic properties. Such foods are beneficial in the prevention and/or treatment of gastritis, duodenal and gastric ulcers caused by infection from Helicobacter pylori (also referred to as H. pylori). The properties of these bacteria are boosted by the addition of egg yolk containing antibodies specific to H. pylori antigen derived from "fractionated H. pylori".

SUMMARY OF THE INVENTION

A natural or synthetic food is supplemented with particular strains of live bacteria which by themselves are effective against Helicobacter pylori (also referred to as H. pylori) not only in vitro but in vivo. Optionally and preferably, the effectiveness of such bacteria is boosted with egg yolk containing antibodies specific to H. pylori antigens, so that consuming the food will prevent and/or treat gastritis, and/or gastric and duodenal ulcers.

It has been discovered that specific strains of non-toxic (to humans) live bacteria, by themselves, when maintained as "active strains" in comestible foods, such as yogurt and other bacteria-tolerant foods which may contain other living organisms, have the unique ability to imbue such foods with prophylactic and/or therapeutic properties because, it is hypothesized, active strains produce bacteriocins which directly attack H. pylori. In the genus of lactic acid bacteria, only the strains Lactococcus sp. HY 49, Lactobacilhus casei HY 2782; and in the genus of Bifidobacterium which is closely related to lactic acid bacteria, only the strain Bifidobacterum longum HY 8001; lodged in the Korean Culture collection, Seoul, Republic of Korea under Depository No. KFCC 10870 for convenience these three together are referred to herein as "active lactic acid bacteria strains" because they have been found either to minimize the growth of, or to destroy H. pylori not only in vitro but also in vivo in the environment of a stomach, provided each strain is used, either individually or in combination, in an effective dosage amount.

It is therefore a general object of this invention to provide a food for general human consumption, comprising a food stored at a temperature in the range from about -45^oC. but no more than 45^oC. and effective to inhibit and/or prevent the growth of H. pylori in a human stomach; the food is most preferably of lactic acid origin; the food is fortified with an active strain selected from the group consisting of Lactococcus sp. HY 49, Lactobacillus casei HY 2782, and Bifidobactedum longum HY 8001, preferably a combination of all three, optionally in combination with antibodies obtained in the yolk of an egg of a hen immunized against a pathogenic factor selected from the group consisting of fractionated H. pylori and urease of H. pylori. "Fractionated H. pylori" consists essentially of a pathogenic factor selected from the group consisting of H. pylori-urease (hereafter referred to only as "urease"), flagella of H. pylori and outer membrane of H. pylori separated from the rest of the mass of H. pylori cells. Portions (ii) and (iii) are typically used together (referred to as "flagella/outer membrane") to avoid the effort of separating them, were each to be used individually. Urease, though not an integral portion of the H. pylori cells is referred to as a constituent of fractionated H. pylori because it is derived from, and separated from the comminuted cells.

It is a specific object of this invention to provide an improved food selected from the group consisting of a conventional food of lactic acid bacterial origin and a non-conventional food, in combination with an effective dosage amount of an active strain selected from the group consisting of Lactococcus sp. HY 49, Lactobacillus casei HY 2782, and Bifidobacterium longum HY 8001, said conventional food being selected from the group consisting of yogurt, buttermilk, cream cheese and ice cream, and said non-conventional food being a nutritional yogurt drink. The useful concentration of active lactic acid bacteria strain(s) in the food is in the range from about 1x10⁸ cfu/ml to about 1x10¹⁰ cfu/ml, preferably in the range from 5x10⁸ cfu/ml to about 5x10¹⁰ cfu/ml, and optimally about 1x10⁹ cfu/ml in a unit serving. The useful concentration of H. pylori-antibodies in egg yolk is in the range from 50 mg to about 250 mg per unit serving, typically in yogurt. The egg yolk is typically used in a fortified food in the range from about 0.05% to about 4% by weight of the food, preferably in the range from 0.5 to 2%, so that at 2% the food contains less than 125 mg of antibodies.

It is another general object of this invention to provide a method of preventing and/or treating disorders associated with infection by H. pylori, the method comprising administering to a human a nutritional food in combination with an effective dosage amount of one or more of the active strains identified immediately hereinabove, in plural successive unit servings, each unit serving spaced apart from a prior one by a period in the range from 1 hour to 3 days; and, preferably to do so in combination with egg yolk powder containing H. pylori-antibodies derived from one or more of the aforespecified pathogenic factors, most preferably all three in combination, wherein the antibodies have been stabilized with from about 5% to about 20% by weight of a water-soluble simple sugar. By a "unit serving" we refer to a conventional individual serving for the particular food being fortified; for example, for yogurt, a typical unit serving is 8 fl oz (fluid ounces) or about 450 ml, though it may range from 4 fl oz to 12 fl oz (250 ml to 950 ml). The term "simple sugar" refers to a carbohydrate containing an .alpha.-hydroxy aldehyde or an .alpha.-keto primary alcohol, preferably sucrose, fructose, lactose, glucose, dextrose and the like.

It is another specific object of this invention to provide a novel adjuvant which is more effective to potentiate an immune response to H. pylori antigens than conventionally used Freund's adjuvant (complete or incomplete) and which not only produces more antibodies than with conventional adjuvants, but also produces more than 75% of the antibodies in the yolk of a hen immunized with an antigen of fractionated H. pylori in the novel adjuvant.

Claim 1 of 16 Claims

We claim:

1. A food for general human consumption, comprising a food stored at a temperature in the range from about -45^oC. but no more than 45^oC., and effective to inhibit and/or prevent the growth of Helicobacter pylori in a human stomach, said food being fortified with an amount effective to inhibit and/or prevent the growth of H. pylori, of an active strain of a non-toxic living microorganism selected from the group consisting of Lactococcus sp. HY 49, Lactobacillus casei HY 2782, and Bifidobacterium longum BY 8001 said strain by itself being effective against H. pylori not only in vitro but also in vivo and produces bacteriocins which directly attack H. pylori.

____________________________________________
If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.