Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
1999-05-26
2001-06-05
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
Reexamination Certificate
active
06241983
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a bacteria- and fiber-containing composition and methods of use thereof for promoting gastrointestinal health. More particularly, the invention relates to a composition comprising living bacteria that are beneficial for gastrointestinal health; soluble and insoluble dietary fiber that provides the advantages typically offered by dietary fibers with the additional advantages of not affecting blood glucose or insulin levels, being readily fermented by the intestinal microflora, and promoting growth of certain beneficial intestinal microorganisms; and optionally one or more of the following: concentrated immunoglobulins capable of binding and inactivating foreign antigens such as pathogenic bacteria, viruses, fungi, and protozoa that are detrimental to gastrointestinal health, lactoperoxidase and/or thiocyanate for strengthening a natural non-immune defense system, lactoferrin for inhibiting detrimental iron-catalyzed processes and harmful microorganisms, and gluconic acid for inhibiting growth of harmful bacteria and stimulating immune function.
Fiber in the diet is well known for its salutary effects on gastrointestinal health. Such effects include providing bulk to the stool, decreasing the pH of the gastrointestinal tract, producing volatile fatty acids, decreasing intestinal transit time, and beneficially influencing various blood parameters. Dietary fiber has also been shown to have a beneficial effect on cholesterol and lipid metabolism that results in decreased serum cholesterol, triglycerides, and phospholipids and an improved (increased) HDL to LDL ratio. A study on laboratory animals showed that adding fiber to the diet decreases the incidence of bacterial translocation, i.e. crossing the intestinal barrier and entering systemic circulation. C. Palacio et al., Dietary Fiber: Physiologic Effects and Potential Applications to Enteral Nutrition, in Clinical Nutrition: Enteral and Tube Feeding (2d. ed., 1990). Nutritional and epidemiological studies have indicated that a general increase in the consumption of dietary fiber may play a role in preventing deleterious effects of oxygen free radicals that have been accused of being involved in such processes as aging, inflammation, and some disease processes. R. Kohen et al., Prevention of Oxidative Damage in the Rat Jejunal Mucosa by Pectin, 69 Br. J. Nutrition 789 (1993).
Certain bacteria have also been shown to be beneficial to human gastrointestinal health. Bacteria of the genus Lactobacillus have been used for several hundred years for treating various illnesses. Lactobacilli found in the human intestinal tract include
L. acidophilus, L. casei, L. fermentum, L. salivaroes, L. brevis, L. leichmannii, L. plantarum,
and
L. cellobiosus.
In recent years,
L. acidophilus
has been shown to be exceptionally useful in treating conditions such as antibiotic-induced imbalances in the gastrointestinal microflora, hypercholesterolemia, vaginal infections,
E. coli
infection, oral contraceptive failure, depressed immunity, cancerous tumors, chronic granulomatous disease, and lactose indigestion. A. G. Shauss, Method of Action, Clinical Application, and Toxicity Data, 3 J. Advancement Med. 163 (1990). In vitro studies have shown
L. acidophilus
to have an inhibitory effect on the growth of pathogenic bacteria such as
Campylobacter pylori, Staphylococcus aureus, Pseudomonas aeruginosa,
and
Sarcina lutea
K. M. Shahani et al., Natural Antibiotic Activity of Lactobacillus Acidophilus and Bulgaricus, 11 Cultured Dairy Products J. 14 (1976).
The beneficial effect of
L. acidophilus
is further illustrated by preliminary evidence that
L. acidophilus
inhibits the toxic activities of bacteria in patients with chronic kidney failure. M. L. Simenhoff et al., Biomodulation of Uremic Pathophysiology in Man, abstract presented at Am. Soc. of Nephrology Meeting, Baltimore, 1992. Such patients often have toxic levels of amines in their blood due to bacterial overgrowth in the small bowel. Consumption of high levels of freeze dried bacteria drastically reduced levels of these toxic amines. These results demonstrate the ability of
L. acidophilus
to exert a positive effect on the microflora of the intestines.
It has also been shown that the activities of fecal bacterial enzymes thought to play a role in conversion of procarcinogens to carcinogens, such as beta-glucuronidase, nitroreductase, and azoreductase, were reduced 2- to 4-fold in subjects taking
L. acidophilus
supplements. B. R. Goldin & L. S. Gorbach, The Effect of Milk and Lactobacillus Feeding on Human Intestinal Bacterial Enzyme Activity, 39 Amer. J. Clin. Nutr. 756 (1984). These results suggest that dietary supplementation with
L. acidophilus
may reduce the risk of developing colon cancer.
Bifidobacteria are also known to exert a beneficial influence on human health. These bacteria exert antimicrobial activity in the human intestine by producing lactic acid and acetic acid as a result of carbohydrate metabolism. These acids lower the intestinal pH, thereby inhibiting overgrowth of gastrointestinal pathogens. Therapeutic applications of bifidobacteria are indicated for the management of diarrhea and constipation, and the management of hepatic encephalopathy with hyperammonemia. Additional benefits include the production of B vitamins and breakdown of carcinogenic N-nitrosamines.
Bifidobacterium adolescentis
is the predominant species of bacteria in humans after age two. This predominance suggests its exceptional stability and prolonged proliferation in the intestine. Nevertheless, for any preparation of living microorganisms to function as a commercial dietary supplement, in addition to being able to provide a beneficial effect must also exhibit good survival in storage, resistance to inactivation by bile, and survival through the gastrointestinal tract. Strain-to-strain or isolate-to-isolate variability can occur as to these traits, thus the selected properties should be verified before commercializing any particular product containing such microorganisms.
While prior art formulas as dietary supplements containing soluble dietary fiber or beneficial bacteria are known and are generally suitable for their limited purposes, they possess certain inherent deficiencies that detract from their overall utility in restoring and maintaining gastrointestinal health. For example, a dietary supplement containing dietary fiber without living intestinal bacteria that are beneficial for gastrointestinal health lack means for providing an inhibitory effect on the growth of pathogenic bacteria, reducing levels of toxic amines, and lowering the pH of the gastrointestinal tract. Similarly, a dietary supplement containing beneficial bacteria without dietary fiber lacks means for providing bulk to the stool, decreasing the pH of the gastrointestinal tract, producing volatile fatty acids, decreasing intestinal transit time, beneficially influencing various blood parameters, beneficially influencing cholesterol and lipid metabolism, decreasing the incidence of bacterial translocation, preventing deleterious effects of oxygen free radicals, and favoring the growth of beneficial bacteria in the gastrointestinal tract. Further, prior art formulas that fail to include concentrated immunoglobulins lack means for binding and inactivating foreign antigens such as pathogenic bacteria, viruses, fungi, and protozoa that can infect the gastrointestinal tract and are detrimental to the health thereof. Further, prior art dietary supplements fail to provide components, such as lactoperoxidase and thiocyanate, that strengthen the body's natural non-immune defense system or LP-system. Moreover, these formulas do not contain inhibitors of detrimental iron-catalyzed processes and stimulators of immune function.
In view of the foregoing, it will be appreciated that a composition for improving and maintaining gastrointestinal health comprising a beneficial human intestinal microorganism and dietary fiber that provides the typical advantages of dietary fiber
Katke Jeffrey J.
Krumhar Kim Carleton
Paul Stephen M.
Clayton Howarth & Cannon, P.C.
Henley III Raymond
Metagenics, Inc.
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