Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2001-02-07
2003-10-07
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S054000
Reexamination Certificate
active
06630452
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to nutritional formulations containing prebiotic substances and the use of such formulations in the growth promotion of beneficial microorganisms and the inhibition of pathogenic organisms. More specifically, this invention relates to nutritional formulations containing oligofructose and sialyllactose.
BACKGROUND OF THE INVENTION
Oligofructose is a series of natural oligosaccharides found primarily in vegetables, such as onion and the root of the chicory plant. Oligofructose is known to be a specific substrate for Bifidobacteria. (See, e.g., Mitsuoka et al, “Effect of Fructo-oligosaccharides on Intestinal Microflora”,
Die Nahrung,
3, 5-6: 427-436 (1987)).
Oligofructose passes through the small intestine without being digested, reaching the large intestine. In the large intestine, oligofructose is fermented only by a limited range of microorganisms that include most species of Bifidobacteria, i.e., species of bacteria beneficial for human health. (See Bouhnik et al, “Short Chain Fructo-Oligosaccharide Administration Dose-Dependently Increases Fecal Bifidobacteria in Healthy Humans,”
J. Nutrition,
129:113-116).
For example, oligofructose can be utilized efficiently by Lactobacilli and Bifidobacteria. It is known that in mixed populations of bacteria such as that which exists in the human colon, oligofructose is consumed preferentially by Bifidobacteria. The other bacteria present in this “mixed population” either do not grow or are inhibited from growing. (See, e.g., Gibson et al, “Selective Stimulation of Bifidobacteria in the Human Colon, by oligofructose and Insulin.”
Gastroenterol,
108:975-982 (1995)).
Moreover, it is known that a metabolic by-product of Bifidobacteria is short chain fatty acids, resulting in a reduction of the pH in the digestive tract. This pH effect has been observed clinically and documented in Mitsuoka et al, “Effect of Fructo-oligosaccharides on Intestinal Microflora”,
Die Nahrung,
3,5-6: 427-438 (1987).
Sialyllactoses are oligosaccharides which occur naturally in human milk as well as in milk of other mammals. However, sialyllactoses are present at noticeably higher concentrations in human milk compared to other mammalian species.
The two primary species of sialyllactose are 3′-sialyllactose and 6′-sialyllactose. These species occur naturally in human milk at a relative ratio of 1:3 (3′:6′). Sialyllactose is known to have anti-adhesive properties for specific pathogenic bacteria. For example, it has been suggested that sialyllactose acts to inhibit cholera toxin (see, Idota et al, “Inhibition of Cholera Toxin by Human Milk Fractions and Sialyllactose,”
Biosci. Biotech. Biochem.
59:417-419) and
Helicobacter pylori
(see, Simon et al, “Inhibition of
Helicobacter pylori
Binding to Gastrointestinal Epithelial Cells by Sialic Acid-Containing Oligosaccharides,”
Infection and Immunity,
750-757, (1997)). In light of its antiadhesive properties, sialyllactose has been used to treat a number of medical conditions. For example, U.S. Pat. Nos. 5,514,660 and 5,753,630, describe the use of sialyllactose in the treatment and inhibition of duodenal ulcers. U.S. Pat. No. 5,883,079 describes the use of sialyllactose to inhibit
H. pylori
infection in mammalian tissue.
However, the use of two prebiotic substances, specifically, oligofructose and sialyllactose, in combination has heretofore not been described. Accordingly, it can be seen that there is a need for such a combination.
SUMMARY OF THE INVENTION
The present invention is related to a nutritional composition, which is effective in increasing beneficial Bifidobacteria and inhibiting the binding of pathogenic microorganisms to human tissue. More specifically, the present invention is directed to nutritional compositions comprising oligofructose and sialyllactose. The present invention is further directed to a method of increasing the concentration of Bifidobacteria and inhibiting the binding of pathogenic bacteria in a human subject comprising enterally administering to said subject a composition comprising oligofructose and sialyllactose.
REFERENCES:
patent: 5514660 (1996-05-01), Zopf et al.
patent: 5753630 (1998-05-01), Zopf et al.
patent: 5883079 (1999-03-01), Zopf et al.
patent: 1129524 (1996-08-01), None
patent: WO94/18986 (1994-09-01), None
patent: WO97/02830 (1997-01-01), None
patent: WO98/31241 (1998-07-01), None
patent: WO99/64022 (1999-12-01), None
patent: WO00/10402 (2000-03-01), None
Mitsuoka et al, “Effect of Fructo-oligosaccharides on Intestinal Microflora”,Die Nahrung, 31, 5-6: 427-436 (1987).
Bouhnik et al, “Short Chain Fructo-oligosaccharide Administration Dose-Dependently Increase Fecal Bifidobacteria In Healthy Humans”,J. Nutrition, 129: 113-116.
Gibson et al, “Selective Stimulation of bifidobacteria in the Human Colon, by Oligofructose and Inulin”,Gastroenterology, 108: 975-982 (1995).
Idota et al, “Inhibition of Cholera Toxin by Human Milk Fractions and Sialyllactose,”Infection and Immunity, 750-757 (1997).
Simon et al, “Inhibition of Helicobacter pylori Binding to Gastrointestinal Epithelial Cells by Sialic Acid-Containing Oligosaccharides,”Infection and Immunity, 750-757 (1997).
Fay Zohreh
Nagy Michael R.
Wyeth
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