TREATMENT OF GLUTEN INTOLERANCE AND RELATED CONDITIONS
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.