Materials and methods for the treatment of celiac disease
View Patent ↗The present invention provides materials and methods for the treatment of celiac disease. In addition, the present invention provides materials and methods of monitoring the treatment of a subject having celiac disease.
1. A method for treating celiac disease in a celiac patient on a gluten-free diet, comprising: administering to the luminal surface of the duodenum of the patient a peptide having the amino acid sequence of SEQ ID NO:15 (Larazotide Acetate), the peptide being administered at least three times daily prior to a meal so as to block persistent intestinal permeability and immune activation, wherein the peptide is administered in an oral dosage capsule comprising enteric-coated multiparticulate beads that are stable in gastric fluid but unstable in intestinal fluid so as to release peptide at the duodenum.
2. The method of claim 1 , wherein the celiac disease is in remission.
3. The method of claim 1 , wherein the patient has an anti-tissue transglutaminase (tTG) level of 10 EU or less.
4. The method of claim 1 , wherein the administering step is for a period of at least two weeks.
5. The method of claim 1 , wherein the peptide is administered about 15 minutes prior to a meal.
6. The method of claim 1 , wherein the capsule comprises from 0.25 mg to 8 mg of the peptide.
7. The method of claim 6 , wherein the capsule comprises about 1 mg of the peptide.
8. A method for treating a celiac patient on a gluten-free diet, comprising: administering to the patient for a period of at least two weeks, an oral dosage capsule comprising enteric-coated beads containing from 0.25 mg to 8 mg of Larazotide acetate, and formulated for delivery to the duodenum, the capsule being administered at least three times daily about 15 minutes prior to a meal, and the capsule comprising enteric-coated multiparticulate beads that are stable in gastric fluid but unstable in intestinal fluid so as to release peptide in the duodenum.