TANNIN AND ANTI-GLIADIN ANTIBODY COMPOSITIONS FOR TREATMENT OF A DISEASE OF THE INTESTINAL TRACT

Abstract

The present invention relates to a composition for use in the treatment of an intestinal tract disorder caused by a gluten-associated protein, said composition comprising at least one agent which binds to the gluten-associated protein, characterized in that the composition is administered at the same time as or at most within 60 minutes after administration of at least one tannin to a patient.

Claims

1.-27. (canceled)

28. A combination preparation suitable for a treatment of a disease of an intestinal tract of a subject, the combination preparation comprising: a first dosage form, wherein the first dosage form comprises at least one agent that binds to a gluten-related protein; and a second dosage form, wherein the second dosage form comprises at least one tannin.

29. The combination preparation of claim 28, wherein the first and the second dosage forms are further defined as oral dosage forms.

30. The combination preparation of claim 28, wherein the agent comprises a protein or polypeptide.

31. The combination preparation of claim 28, wherein the agent is an antibody, an antibody fragment, an aptamer, a designed ankyrin repeat protein, or a specific receptor directed against the gluten-related protein.

32. The combination preparation of claim 31, wherein the agent is an immunoglobulin Y antibody.

33. The combination preparation of claim 31, wherein the agent is a polyclonal antibody from a mammal, a polyclonal antibody from a bird, an antibody from a lizard, a monoclonal antibody, or an antibody from lungfish blood.

34. The combination preparation of claim 31, wherein the agent is an anti-gliadin antibody or a gliadin-binding fragment thereof.

35. The combination preparation of claim 28, wherein the disease of the intestinal tract is caused by a gluten-related protein.

36. The combination preparation of claim 28, wherein the disease of the intestinal tract is a celiac disease.

37. The combination preparation of claim 36, wherein the celiac disease is asymptomatic celiac disease, classical celiac disease, subclinical celiac disease, symptomatic celiac disease, refractory celiac disease, latent celiac disease, potential celiac disease, celiac disease autoimmunity, gluten intolerance, non-celiac gluten sensitivity, or a gluten-associated disorder.

38. The combination preparation of claim 28, wherein the at least one tannin is a gallotannin, catechol tannin, Lamiacea tannin, or algal tannin.

39. The combination preparation of claim 28, further comprising at least one bacterial protease.

40. The combination preparation of claim 28, further comprising prolylendopeptidase.

41. The combination preparation of claim 28, further comprising at least one eukaryotic and/or prokaryotic cell capable of reducing and/or suppressing inflammatory processes in a stomach and/or an intestinal tract.

42. The combination preparation of claim 41, wherein the at least one cell is further defined as a cell of Flavobacterium sp., Lactobacillus sp., Aspergillus sp., or Bifidobacterium sp.

43. The combination preparation of claim 41, wherein the composition comprises an amount of the at least one cell of 10.sup.9 to 10.sup.14 cells.

44. The combination preparation of claim 28, wherein the combination preparation comprises 10 mg to 10,000 mg of the at least one tannin.

45. The combination preparation of claim 28, wherein the combination preparation comprises 1 mg to 15,000 mg of the at least one agent that binds to a gluten-related protein.

46. A kit suitable for a treatment of a disease of an intestinal tract, the kit comprising at least one dose of at least one tannin and at least one dose of at least one agent that binds to a gluten-related protein.

47. The kit of claim 46, wherein said doses are further defined as oral doses.

Description

ADDITIONAL EMBODIMENTS

[0058] 1. A composition comprising at least one tannin for treatment of an inflammatory disease of the stomach and/or the intestinal tract, wherein the composition is administered in combination with at least one second agent for treatment of an inflammatory disease of the stomach and/or the intestinal tract. [0059] 2. The composition according to embodiment 1, characterized in that the inflammatory disease of the stomach and/or of the intestinal tract is selected from the group consisting of celiac disease, Crohn's disease, colitis, in particular cystic colitis, hemorrhagic colitis, ischemic colitis, pseudomembranous colitis or ulcerative colitis, irritable bowel and gastritis. [0060] 3. The composition according to embodiment 1 or 2, characterized in that the at least one second agent for treatment of an inflammatory disease of the stomach and/or of the intestinal tract comprises at least protein or polypeptide, which binds at least one substance that induces or mediates the inflammatory disease. [0061] 4. The compositions according to embodiment 3, characterized in that the at least one protein or polypeptide is an antibody, an aptamer and/or a DARpin (“designed ankyrin repeat protein”) directed against a substance which induces or mediates the inflammatory reaction, or a specific receptor directed against an active ingredient that induces or mediates the inflammatory reaction. [0062] 5. The composition according to embodiment 4, characterized in that the at least one antibody, aptamer and/or DARpin is directed against gliadin and/or fragments thereof, in particular against tryptically and/or peptically cleaved gliadin or physiologically equivalent metabolites of gluten or gluten fractions. [0063] 6. The composition according to any one of embodiments 3 or 5, characterized in that the at least one protein or polypeptide, in particular the at least one antibody is of a recombinant origin. [0064] 7. The composition according to embodiment 4 or 5, characterized in that the at least one antibody is a polyclonal antibody from mammals, a polyclonal antibody of avian origin, an antibody from lizards, a monoclonal antibody or an antibody from the blood of lungfish. [0065] 8. The composition according to any one of embodiments 1 to 5, characterized in that the at least one agent for treatment of an inflammatory disease of the stomach and/or the intestinal tract comprises eukaryotic cells and/or prokaryotic cells, which are capable of reducing and/or suppressing inflammatory processes in the stomach and/or the intestinal tract. [0066] 9. The composition according to embodiment 8, characterized in that the eukaryotic and/or prokaryotic cells are selected from the group consisting of Flavobacterium sp., Lactobacillus sp., Aspergillus sp. and Bifidobacterium sp. [0067] 10. The composition according to any one of embodiments 1 to 9, characterized in that the at least one tannin is selected from the group consisting of tannins, catechol tannins, Lamiaceae tannins and algal tannins. [0068] 11. The composition according to any one of embodiments 1 to 8, characterized in that the at least one tannin is precipitated in advance with at least one protein. [0069] 12. The composition according to embodiment 11, characterized in that the at least one protein is an antibody defined as in one of embodiments 4 to 7. [0070] 13. The composition according to any one of embodiments 1 to 10, characterized in that the at least one tannin and the at least one agent for treatment of an inflammatory disease of the stomach and/or of the intestinal tract are present in a formulation for controlled release in the stomach and/or the intestinal tract, preferably the intestinal tract. [0071] 14. The composition according to any one of embodiments 1 to 13, characterized in that the composition comprising at least one tannin is administered simultaneously with and/or before the at least one agent for treatment of an inflammatory disease of the stomach and/or of the intestinal tract. [0072] 15. The composition according to any one of embodiments 1 to 14, characterized in that the composition comprising at least one tannin is administered at least one minute, preferably at least five minutes, more preferably at least ten minutes, most preferably at least 20 minutes before the at least one agent for treatment of an inflammatory disease of the stomach and/or of the intestinal tract. [0073] 16. The composition according to any one of embodiments 1 to 15, characterized in that the composition, comprising at least one tannin, is administered in an amount of 100 mg to 10,000 mg, preferably 100 mg to 5,000 mg, more preferably 100 mg to 2,500 mg, especially preferably 500 mg to 2,000 mg. [0074] 17. The composition according to any one of embodiments 3 to 7 and 10 to 16, characterized in that the at least one protein or polypeptide, which binds to the at least one substance that induces or mediates the inflammatory disease, is administered in an amount of 200 mg to 100,000 mg, preferably 200 mg to 50,000 mg, more preferably 200 mg to 20,000 mg, in particular preferably 500 mg to 15,000 mg. [0075] 18. The composition according to any one of embodiments 8 to 17, characterized in that the eukaryotic and/or prokaryotic cells are administered in an amount of 10.sup.9 to 10.sup.14, preferably 10.sup.10 to 10.sup.13, [0076] 19. A set for treatment of an inflammatory disease of the stomach and/or of the intestinal tract, comprising at least one container with at least one tannin and at least one additional container with at least one agent for treatment of an inflammatory disease of the stomach and/or of the intestinal tract. [0077] 20. The set according to embodiment 19, as defined in one of the embodiments 1 to 18.