Bile preparations for colorectal disorders
First Claim
1. A method of protecting a colorectum against adenomatous polyposis coli in a subject comprising:
- administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values.
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Abstract
The present disclosure relates to methods and compositions to ameliorate or treat at least one symptom of colorectal cancer and/or adenomatous polyposis coli (APC). For example, some embodiments of the methods and compositions may reduce recurrence of colorectal adenomas and/or extend the life of a subject having colorectal cancer and/or APC. Some embodiments of the disclosure include maintaining a the total body weight in a subject having colorectal cancer and/or APC. According to some embodiments, a method of the disclosure may include administering a bile acid composition to a subject. A bile acid composition may include, in some embodiments, an aqueous solution that is free or substantially free of precipitates or particles. A aqueous solution may include (1) a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, and/or 7-ketolithocholic acid, (2) a carbohydrate, and (3) water. An aqueous composition may further include an alkali.
60 Citations
45 Claims
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1. A method of protecting a colorectum against adenomatous polyposis coli in a subject comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (9, 11)
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2. A method of extending a life of a subject having adenomatous polyposis coli, said method comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values.
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3. A method of maintaining a total body weight in a subject having adenomatous polyposis coli, said method comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values.
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4. A method of ameliorating or treating at least one symptom of adenomatous polyposis coli in a subject having or at risk of having adenomatous polyposis coli, said method comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values.
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5. A method of reducing recurrence of colorectal adenomas in a colorectum of a subject comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values.
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6. A method of extending a life of a subject having colorectal cancer, said method comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values.
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7. A method of maintaining a total body weight in a subject having colorectal cancer, said method comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values.
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8. A method of ameliorating or treating at least one symptom of colorectal cancer in a subject having or at risk of having colorectal cancer, said method comprising:
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administering to the subject a composition comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble dietary carbohydrate that escape digestion and absorption in the small intestine, and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
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38. A clear aqueous solution comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, and 7-ketolithocholic acid;
(b) a carbohydrate selected from the group consisting of an aqueous soluble starch conversion product, an aqueous soluble digestion resistant maltodextrin (fibersol-2), and combinations thereof; and
(c) water, wherein the first material and the carbohydrate both remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (39)
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40. An aqueous solution comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, and a bile acid conjugated with an amine by an amide linkage;
(b) a second material comprising a high molecular weight aqueous soluble starch conversion product; and
(c) water, wherein the first and second materials both remain in solution for all pH values of the solution within a selected range of pH values. - View Dependent Claims (41, 42, 43)
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44. A method of protecting a colorectum against adenomatous polyposis coli in a subject comprising:
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administering to the subject a dried form of a primary aqueous solubilized bile acid formulation comprising;
(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and, combinations thereof;
(b) a second material selected from the group consisting of an aqueous soluble starch conversion product, a resistant maltodextrin, an aqueous soluble non-starch polysaccharide, and combinations thereof; and
,(c) a third material selected from aqueous soluble ginseng extract, aqueous soluble red ginseng extract, and combinations thereof.
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45. A dried form of a primary aqueous solubilized bile acid formulation comprising:
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(a) a first material selected from the group consisting of a bile acid, an aqueous soluble derivative of a bile acid, a bile acid salt, a bile acid conjugated with an amine by an amide linkage, and combinations thereof; and
(b) an aqueous soluble starch conversion product;
wherein the first material and the aqueous soluble starch conversion product both remain in solution for all pH values of the solution within a selected range of pH values.
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Specification