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.
1. A solid composition for treating or attenuating gluten intolerance comprising:
(a) an effective amount of nepenthesin selected from the group consisting of a nepenthesin I salt, a nepenthesin II salt, or a combination thereof, and
(b) an effective amount of a buffer to maintain the pH of said solid composition at a pH of 5 or above, wherein said nepenthesin is inactive prior to administration;
wherein said effective amount of nepenthesin is sufficient to degrade gluten upon oral administration of said solid composition to a patient suffering from gluten intolerance.
2. The solid composition of claim 1 , wherein said effective amount of nepenthesin is between about 1 mg and about 1 g, wherein about refers to a variation of up to ±5%.
3. The solid composition of claim 1 , further comprising at least one additional agent selected from the group consisting of an inhibitor of a transglutaminase, an anti-inflammatory agent, a COX-2 inhibitor, a p38 MAP kinase inhibitor, a mast cell-stabilizing agent, an anti-ulcer agent, an anti-allergy agent, and an anti-TNF-α agent.
4. The solid composition of claim 1 , further comprising at least one additional enzyme selected from the group consisting of a gastric protease, an aspartic protease, and a prolyl endopeptidase.
5. The solid composition of claim 1 , wherein said composition is formulated to release said nepenthesin in a patient's stomach.
6. The solid composition of claim 2 , wherein said effective amount of said nepenthesin is between about 1 mg and about 500 mg.
7. The solid composition of claim 2 , wherein said effective amount of said nepenthesin is between about 1 mg and about 200 mg.
8. The solid composition of claim 1 , wherein said gluten intolerance is celiac disease, wheat allergy, gluten sensitivity, or dermatitis herpetiformis.