Methods and compositions for treating bile acid diarrhea, diarrhea associated with small intestine resection or gallbladder removal, and short bowel syndrome

11779,564

16/617466

May 31, 2018

Presented herein are methods for treating bile acid diarrhea, short bowel syndrome (SBS), and cholecystectomy-associated diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. In particular embodiments, infants, and juveniles with SBS are treated with an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.

NAPO PHARMACEUTICALS, INC. (San Francisco, CA, US)

NAPO PHARMACEUTICALS, INC. (San Francisco, CA, US)

1. A method of treating short bowel syndrome (SBS) or secretory diarrhea associated therewith in a subject comprising administering to a subject in need thereof an amount of proanthocyanidin polymer composition from C. lechleri effective to treat SBS or secretory diarrhea associated therewith.

2. The method of claim 1 , wherein the SBS results from surgical resection of the intestine.

3. The method of claim 1 , wherein the SBS is due to a congenital deficiency.

4. The method of claim 1 , wherein the subject is an infant.

5. The method of claim 4 , wherein the subject suffers from necrotizing enterocolitis.

6. The method of claim 5 , wherein the subject suffers from intestinal anomalies, midgut volvulus, intestinal atresia, abdominal wall defect, malrotation, or long segment Hirschsprung's disease.

7. The method of claim 4 , wherein, the subject to be treated is an infant within 1 week of birth, within 2 weeks of birth, within 1 month of birth, or within 6 months of birth.

8. The method of claim 4 , wherein the infant is premature or was born prematurely.

9. The method of claim 1 wherein the subject to be treated is a non-infant juvenile or adult.

10. The method of claim 1 , in which a portion of the large intestine or colon is also resected.

11. The method of claim 10 , wherein the subject does not have all or a portion of the duodenum, the jejunum or the ileum, or a combination thereof.

12. The method of claim 1 , wherein the subject is administered parenteral nutrition.

13. The method of claim 1 , wherein the administration results in improvement in a hepatic and/or biliary disorder associated with the SBS and/or results in a reduction in the risk or incidence of liver failure or wherein the administration results in an improvement in hypotension, metabolic bone disease, small bowel bacterial overgrowth, enteric hyperoxaluria, D-lactic acidosis, risk of infection and/or wound healing.

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