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Claims for Patent: 5,601,848

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Claims for Patent: 5,601,848

Title: Methods for the treatment of gastrointestinal disorders
Abstract:Method for the treatment of human and lower animals having an infectious gastrointestinal disorder, comprising the step of administering from about 50 to about 5000 milligrams of bismuth to said subject, per day, for from 3 to 56 days. Preferred processes also include a step for performing a diagnostic step on the subject for detection of campylobacter-like organism infection of the subject.
Inventor(s): Marshall; Barry J. (Perth, AU)
Assignee: The Procter & Gamble Company (Cincinnati, OH)
Application Number:07/070,857
Patent Claims: 1. A method, for the treatment of a human or lower animal subject having an infectious gastrointestinal disorder caused or mediated by Campylobacter pyloridis, by combating said Campylobacter pyloridis infection in said subject, comprising the step of orally administering to said subject from about 50 milligrams to about 5000 milligrams of bismuth, per day, for from 3 to 56 days, wherein said bismuth is selected from the group consisting of bismuth aluminate, bismuth subcarbonate, bismuth citrate, bismuth subgalate, bismuth subnitrate, bismuth tartrate, bismuth subsalicylate, and mixtures thereof.

2. A method, according to claim 1, wherein said bismuth is administered at a level of from about 500 to about 1500 milligrams, per day.

3. A method, according to claim 1, for the treatment of a human or lower animal subject having a non-ulcerative gastrointestinal disorder, wherein said bismuth is administered for from 3 to 21 days.

4. A method, according to claim 1, for the treatment of a human or lower animal subject having peptic ulcer disease, wherein said bismuth is administered for from 14 to 56 days.

5. A method, according to claim 3, wherein said bismuth is bismuth subsalicylate.

6. A method, according to claim 4, wherein said bismuth is bismuth subsalicylate.

7. A method, for the treatment of a human or lower animal subject having an infectious gastrointestinal disorder caused or mediated by Campylobacter pyloridis, by combating said Campylobacter pyloridis infection in said subject, comprising the steps of:

(a) performing a diagnostic test on said subject, for the detection of a Campylobacter pyloridis infection of said subject; and, upon obtaining a positive result from said diagnostic test,

(b) orally administering to said subject from about 50 milligrams to about 5000 milligrams of bismuth, per day, for from 3 to 56 days, wherein said bismuth is selected from the group consisting of bismuth aluminate, bismuth subcarbonate, bismuth citrate, bismuth subgalate, bismuth subnitrate, bismuth tartrate, bismuth subsalicylate, and mixtures thereof.

8. A method, according to claim 7, wherein said bismuth is administered for a period of time ending when said subject is tested with said diagnostic test and a negative result is obtained.

9. A method for treating peptic ulcer disease caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5,000 milligrams of bismuth, per day, for from 3 to 56 days.

10. A method, according to claim 9, wherein said bismuth is selected from the group consisting of bismuth aluminate, bismuth subcarbonate, bismuth subcitrate, bismuth citrate, tripotassium dicitrato bismuthate, bismuth subgalate, bismuth subnitrate, bismuth tartrate, bismuth subsalicylate, and mixtures thereof.

11. A method, according to claim 10, wherein said bismuth is tripotassium dicitrato bismuthate.

12. A method, according to claim 10, wherein said bismuth is bismuth subsalicylate.

13. A method for treating non-ulcerative gastrointestinal disorder caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5000 milligrams of bismuth, per day, for from 3 to 56 days, wherein said bismuth is selected from the group consisting of bismuth aluminate, bismuth subcarbonate, bismuth citrate, bismuth subgalate, bismuth subnitrate, bismuth tartrate, bismuth subsalicylate, and mixtures thereof.

14. A method, according to claim 13, wherein said bismuth is bismuth subsalicylate.

15. A method for treating non-ulcerative dyspepsia caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5000 milligrams of bismuth, per day, for from 3 to 56 days, wherein said bismuth is selected from the group consisting of bismuth aluminate, bismuth subcarbonate, bismuth citrate, bismuth subgalate, bismuth subnitrate, bismuth tartrate, bismuth subsalicylate, and mixtures thereof.

16. A method, according to claim 15, wherein said bismuth is bismuth subsalicylate.

17. A method for treating gastritis caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5000 milligrams of bismuth, per day, for from 3 to 56 days, wherein said bismuth is selected from the group consisting of bismuth aluminate, bismuth subcarbonate, bismuth citrate, bismuth subgalate, bismuth subnitrate, bismuth tartrate, bismuth subsalicylate, and mixtures thereof.

18. A method for treating gastritis caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5,000 milligrams of bismuth, per day, for from 3 to 21 days, wherein said bismuth is bismuth subsalicylate.

19. A method for treating duodenal ulcers caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5,000 milligrams of bismuth, per day, for from 14 to 56 days, wherein said bismuth is bismuth subsalicylate.

20. A method for treating duodenal ulcers caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5,000 milligrams of bismuth, per day, for from 14 to 56 days, wherein said bismuth is tripotassium dicitrato bismuthate.

21. A method for treating gastric ulcers caused or mediated by Campylobacter pyloridis by combating said Campylobacter pyloridis infection in a human or lower animal subject comprising the step of orally administering to said subject from about 50 milligrams to about 5,000 milligrams of bismuth, per day, for from 14 to 56 days, wherein said bismuth is tripotassium dicitrato bismuthate.

22. A method of treating patients suffering from non-ulcer dyspepsia associated with Campylobacter pyloridis infection, said method comprising administering to said patients a composition comprising pharmaceutically acceptable bismuth salt in an amount effective to clear said patients of dyspeptic symptoms.
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