Treatment of gluten intolerance and related conditions

Abstract

Provided herein are compositions, foods comprising nepenthesin or a derivative thereof and methods of using nepenthesin or a derivative thereof for modulating gluten intolerance and related conditions, such as celiac disease. Further provided herein are pharmaceutical compositions comprising nepenthesin or a derivative thereof and methods of using nepenthesin or a derivative thereof to treat bacterial infections of the gastrointestinal tract, such as C. difficile or H. pylori . Further provided herein are compositions comprising recombinant nepenthesin I or nepenthesin II, or homologous proteins, and methods for making the same.

1 .- 44 . (canceled) 
     
     
         45 . A composition suitable for treating celiac disease, the composition comprising a pharmaceutically acceptable excipient and an effective amount of nepenthesin so as to treat celiac disease in a patient in need thereof, wherein the nepenthesin is in an inactive form. 
     
     
         46 . The composition of  claim 45  which is at a pH of about or above 5. 
     
     
         47 . The composition of  claim 45  which is in an aqueous formulation. 
     
     
         48 . The composition of  claim 47  which is sterile. 
     
     
         49 . The composition of  claim 47  which is in a form selected from the group consisting of a solution, a suspension, an emulsion, a capsule, and a syrup. 
     
     
         50 . The composition of  claim 45  which is in a solid formulation. 
     
     
         51 . The composition of  claim 50  which is in a form selected from the group consisting of a tablet, a pill, a capsule, a powder, and a sustained release formulation. 
     
     
         52 . The composition of  claim 45 , wherein the nepenthesin comprises recombinant nepenthesin I, recombinant nepenthesin II, or a mixture thereof. 
     
     
         53 . The composition of  claim 45 , wherein the nepenthesin comprises a fragment of nepenthesin which retains proteolytic activity. 
     
     
         54 . The composition of  claim 53 , wherein the fragment of nepenthesin has at least about 20 contiguous amino acids of the full nepenthesin protein.