COMPOSITIONS AND METHODS FOR TREATING OR PREVENTING ENVIRONMENTAL ENTEROPATHY
The present invention provides compositions and methods for treating or preventing environmental enteropathy and associated intestinal damage. The compositions comprise Larazotide or Larazotide derivatives.
1 . A method for treating or preventing environmental enteropathy (EE) or intestinal damage resulting from exposure to fecal pathogens, comprising administering an effective amount of a composition comprising Larazotide or a derivative thereof to a subject in need thereof.
2 . The method of claim 1 , wherein the subject is administered a composition releasing Larazotide or a derivative in the small and/or large intestine.
3 . The method of claim 2 , wherein the composition releases Larazotide or derivative in one or more of the duodenum, jejunum, and/or the ileum.
4 . The method of claim 2 , wherein the composition releases Larazotide or derivative in the cecum, the ascending colon, the transverse colon, the descending colon, and/or the sigmoid colon.
5 . The method of claim 2 , wherein the subject is administered one or more compositions releasing Larazotide in the small and large intestine.
6 . The method of any one of claims 1 to 5 , wherein the subject is a pediatric subject.
7 . The method of any one of claims 1 to 5 , wherein the subject is an adult.
8 . The method of any one of claims 1 to 7 , wherein the subject has EE.
9 . The method of any one of claims 1 to 7 , wherein the subject is at risk of EE.
10 . The method of claim 9 , wherein the subject lives in an environment of poor sanitation or prevalence of EE.
11 . The method of claim 9 or 10 , wherein the subject is exposed to food or water contaminated with focal pathogens.
12 . The method of any one of claims 1 to 11 , wherein the composition is a controlled-release or sustained-release formulation.
13 . The method of claim 12 , wherein the composition releases Larazotide or derivative in the small intestine at a dose of from about 0.1 mg to about 5 mg.
14 . The method of claim 13 , wherein the composition releases Larazotide or derivative in the small intestine at a dose of from about 0.1 mg to about 1 mg.
15 . The method of claim 12 , wherein the composition releases Larazotide or derivative in the large intestine at a dose of from about 0.1 mg to about 5 mg.
16 . The method of claim 15 , wherein the composition releases Larazotide or derivative in the large intestine at a dose of from about 0.1 mg to about 1 mg.
17 . The method of any one of claims 12 to 16 , wherein a single composition targets release of Larazotide or derivative in the small intestine and large intestine.
18 . The method of any one of claims 12 to 16 , wherein different compositions target release of Larazotide or derivative in the small intestine and large intestine.
19 . The method of any one of claims 1 to 18 , wherein the composition is administered more than once daily.
20 . The method of any one of claims 1 to 19 , the Larazotide or derivative regimen is for a prolonged period.
21 . The method of any one of claims 1 to 20 , wherein the subject further receives antibiotic therapy.
22 . The method of claim 21 , wherein antibiotic therapy is delivered before or during therapy with Larazotide or derivative.
23 . The method of claim 21 , wherein antiviral therapy is delivered before or during therapy with Larazotide or derivative.
24 . The method of any one of claims 1 to 22 , wherein the subject further receives a probiotic.
25 . The method of claim 24 , wherein the probiotic is delivered after antibiotic therapy, together with therapy with Larazotide or derivative.
26 . The method of many of claims 1 to 23 , wherein the Larazotide or derivative is administered with or after an antidiarrheal agent.