IP Library Patent Application 12851216
Patent Application
App. No. 12/851,216

METHODS AND MATERIALS FOR TREATING DIARRHEA

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Quick Facts
Patent No.
US None
App. No.
12/851,216
Abstract

This document relates to methods and materials for administering bile acid sequestrants to treat conditions associated with diarrhea. For example, formulations designed for the delivery of a bile acid sequestrant (e.g., colesevelam) to treat diarrhea are provided.

Claims (14)

1 . A method for treating a diarrhea condition, said method comprising administering to a mammal having said diarrhea condition a composition comprising a bile acid sequestrant.

2 . The method of claim 1 , wherein said mammal is a human.

3 . The method of claim 1 , wherein said diarrhea condition is bile acid malabsorption induced diarrhea.

4 . The method of claim 1 , wherein said bile acid sequestrant is colesevelam.

5 . The method of claim 1 , wherein said composition is administered to said mammal under conditions wherein the amount of said bile acid sequestrant in said composition is between about 1 gram and about 5 grams.

6 . The method of claim 5 , wherein said composition is administered to said mammal between once every other day to four times a day.

7 . The method of claim 1 , wherein said method comprises assessing said mammal before said administering step to determine if said mammal comprises a serum level of 7αC4 greater than about 25 ng/mL of serum, wherein the presence of said serum level indicates that said mammal is to be administered said bile acid sequestrant.

8 . The method of claim 7 , wherein said serum level of 7αC4 is a fasting serum level of 7αC4.

9 . The method of claim 1 , wherein said method comprises assessing said mammal before said administering step to determine if said mammal comprises a serum level of 7αC4 greater than about 30 ng/mL of serum, wherein the presence of said serum level indicates that said mammal is to be administered said bile acid sequestrant.

10 . A method for treating a diarrhea condition, said method comprising (a) identifying a mammal having said diarrhea condition and a serum level of 7αC4 greater than about 25 ng/mL of serum, and (b) administering a composition comprising a bile acid sequestrant to said identified mammal under conditions wherein the severity of said diarrhea condition is reduced.

11 . The method of claim 10 , wherein said serum level of 7αC4 is a fasting serum level of 7αC4.

12 . A method for treating a diarrhea condition, said method comprising (a) identifying a mammal having (i) said diarrhea condition, (ii) a serum level of 7αC4 greater than about 20 ng/mL of serum, and (iii) a potential bile acid malabsorption condition based on a fecal bile acid excretion test or 75 SeHCAT retention test, and (b) administering a composition comprising a bile acid sequestrant to said identified mammal under conditions wherein the severity of said diarrhea condition is reduced.

13 . The method of claim 12 , wherein said fecal bile acid excretion test is a 48 hour fecal bile acid excretion test.

14 . The method of claim 12 , wherein said 75 SeHCAT retention test is a 75 SeHCAT retention test at 7 days.

Assignments (3)
SECURITY AGREEMENT Recorded Feb 9, 2012
From: PHYSIO-CONTROL, INC.
To: BANK OF NEW YORK MELLON TRUST COMPANY, N.A., AS *COLLATERAL TRUSTEE, THE
Reel/Frame 027765/0861 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 26, 2010
From: CAMILLERI, MICHAEL L.
To: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
Reel/Frame 024888/0887 →
CONFIRMATORY LICENSE Recorded Aug 20, 2010
From: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 024865/0661 →