Methods for diagnosing and treating dysautonomia and other dysautonomic conditions

• US 20040115182A1
• Filed: 12/08/2003
• Published: 06/17/2004
• Est. Priority Date: 08/14/2000
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Joan M. Fallon
• Inventors: Fallon, Joan M.
• Granted Patent: US 7,138,123 B2
• Time in Patent Office: Days
• US Class Current: 424/94.2
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/2235 Secretins
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)

Abstract

Methods for aiding in the diagnosis of dysautonomic disorders and dysautonomic conditions and methods for treating individuals diagnosed as having a dysautonomic disorder or a dysautonomic condition. In one aspect, a diagnosis method comprising analyzing a stool sample of an individual for the presence of a biological marker wherein the quantity of the biological marker is an indication of whether the invidual has, or can develop, a dysuatonic disorder or dysautonomic condition, as well as a therapuetic method for treating a dysautonomic disorder or dysautonomic condition by administration of, e.g., secretin, neuropeptides, peptides and/or digestive enzymes.

Claims

1. A method for treating a dyautonomic disorder with secretin, the method comprising the step of administering to an individual having the disorder an effective amount of secretin to improve a symptom of the disorder.

2. The method of claim 1, further comprising the step of analyzing a compound in a stool sample of the individual, wherein the administration of secretin is based on the analysis of the stool sample.

3. The method of claim 1, wherein the compound comprises a pancreatic enzyme.

4. The method of claim 1, wherein the pancreatic enzyme comprises chymotrypsin.

5. The method of claim 4, wherein the step of analyzing the stool sample comprises the steps of:

measuring a quantitative level of chymotrypsin present in the stool sample; and

comparing the measured quantitative level with at least one threshold chymotrypsin level to determine the efficacy of secretin administration to the individual.

6. The method of claim 5, wherein the at least one threshold chymotrypsin level is based on a level of chymotrypsin associated with at least one other individual of the same approximate age that does not have the disorder.

7. The method of claim 5, wherein the at least one threshold chymotrypsin level is approximately 8.4 U/gm.

8. The method of claim 5, wherein the at least one threshold chymotrypsin level is approximately 4.2 U/gm.

9. The method of claim 1, wherein the disorder comprises Familial dysautonomia (Riley-Day Syndrome).

10. The method of claim 1, wherein the disorder comprises Parkinson'"'"'s disease.

11. The method of claim 1, wherein the disorder comprises a disorder of the catecholamine dysfunction.

12. The method of claim 1, wherein the disorder comprise baroreflex failure.

13. The method of claim 1, wherein the disorder comprise dopamine-B Hydroxylase deficiency.

14. The method of claim 1, wherein the disorder comprises familial paraganglioma syndrome.

15. The method of claim 1, wherein the disorder comprises aromatic-L-amino acid decarboxylase deficiency.

16. The method of claim 1, wherein the disorder comprises Menke'"'"'s disease.

17. The method of claim 1, wherein the disorder comprises tetrahydrobiopterin deficiency.

18. The method of claim 1, wherein the disorder comprises a monoamine oxidase deficiency state.

19. The method of claim 1, wherein the disorder comprises a catecholamine type tumor or lesion as a pheochromocytoma chemodectina or neuroblasoma.

20. The method of claim 1, wherein the disorder comprises Hereditary Sensory and autonomic neuropathy type III (HSAN III).

21. The method of claim 1, wherein the disorder comprises a central autonomic disorder type.

22. The method of claim 1, wherein the disorder comprises multiple system atrophy (Shy-Drager syndrome).

23. The method of claim 1, wherein the disorder comprise an orthostatic intolerance syndrome.

24. The method of claim 1, wherein the disorder comprises mitral valve prolapse.

25. The method of claim 1, wherein the disorder comprises postural tachycardia syndrome (POTS).

26. The method of claim 1, wherein the disorder comprises idiopathic hypovolemia.

27. The method of claim 1, wherein the disorder comprises a disorder of dopamine metabolism.

28. The method of claim 1, wherein the disorder comprises a disorder of the cardiovascular system.

29. The method of claim 1, wherein the disorder comprises hypertension.

30. The method of claim 1, wherein the disorder comprise Gullain-Barre syndrome (acute idiopathic polyneuropathy).

31. The method of claim 1, wherein the disorder comprises Chaga'"'"'s disease.

32. The method of claim 1, wherein the disorder comprises pure autonomic failure.

33. The method of claim 1, wherein the disorder comprises diabetic autonomic failure.

34. The method of claim 1, wherein the disorder comprise a mitochondrial disease.

35. The method of claim 1, wherein the disorder comprises syncope.

36. The method of claim 1, wherein the disorder comprises renal disease.

37. The method of claim 1, wherein the disorder comprises fetal fatal insomnia.

38. The method of claim 1, wherein the disorder comprises Sudden Infant Death Syndrome (SIDS).

39. A method for treating a dyautonomic disorder or condition with peptides, the method comprising the step of administering to an individual having the disorder an effective amount of peptides to improve a symptom of the disorder.

40. The method of claim 39, further comprising the step of analyzing a compound in a stool sample of the individual, wherein the administration of peptides is based on the analysis of the stool sample.

41. The method of claim 39, wherein the compound comprises a pancreatic enzyme.

42. The method of claim 39, wherein the pancreatic enzyme comprises chymotrypsin.

43. The method of claim 42, wherein the step of analyzing the stool sample comprises the steps of:

measuring a quantitative level of chymotrypsin present in the stool sample; and

comparing the measured quantitative level with at least one threshold chymotrypsin level to determine the efficacy of peptide administration to the individual.

44. A method for treating a dyautonomic disorder with digestive enzymes, the method comprising the step of administering to an individual having the disorder an effective amount of digestive enzymes to improve a symptom of the disorder.

45. The method of claim 44, further comprising the step of analyzing a compound in a stool sample of the individual, wherein the administration of digestive enzymes is based on the analysis of the stool sample.

46. The method of claim 44, wherein the compound comprises a pancreatic enzyme.

47. The method of claim 44, wherein the pancreatic enzyme comprises chymotrypsin.

48. The method of claim 47, wherein the step of analyzing the stool sample comprises the steps of:

measuring a quantitative level of chymotrypsin present in the stool sample; and

comparing the measured quantitative level with at least one threshold chymotrypsin level to determine the efficacy of digestive enzyme administration to the individual.

49. A method for determining if an individual has, or can develop, a dysautonomic disorder or condition, comprising the steps of:

obtaining a stool sample from the individual;

analyzing a compound in the stool sample; and

correlating the analysis of the compound with a dysautonomic disorder or condition or lack thereof.

50. The method of claim 49, wherein the compound comprises a pancreatic enzyme.

51. The method of claim 49, wherein the compound comprises a digestive enzyme.

52. The method of claim 49, wherein the compound comprises chymotrypsin.

53. The method of claim 49, wherein the step of analyzing comprises the step of determining a quantity of the compound in the stool sample.

54. The method of claim 49, wherein the step of correlating comprises the step of comparing the quantity of the compound in the stool sample with a normal quantity of the compound found in an individual that does not have a dysautonomic disorder.

55. The method of claim 53, wherein the quantity of the compound in the stool is indicative of abnormal pancreatic function.

56. The method of claim 53, wherein the quantity of the compound in the stool is indicative of abnormal protien digestion and metabolism.

57. The method of claim 49, wherein the compound in the stool is indicative of an inflammatory process.