Diagnosis and treatment of motility disorders of the gut and bladder, and of fibromyalgia

Abstract

Described herein are methods and systems for the detection of anti-vinculin antibodies, for determining a presence or likely presence of a gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia. Further provided are methods of selecting and/or administering a therapy based on the presence or absence of anti-vinculin antibodies.

1 . A method, comprising:
 providing a biological sample from a subject desiring diagnosis of a gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia;   detecting in the biological sample, a presence or a level of an anti-vinculin antibody; and   determining a presence or likely presence of the gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia if the presence of the anti-vinculin antibody is detected, if the level of the anti-vinculin antibody is higher than an established control level, or if the level of the anti-vinculin antibody is significantly higher than an established control level, or   determining an absence or likely absence of the gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia if an absence of the anti-vinculin antibody is detected, if the level of the anti-vinculin antibody is equal to or lower than an established control level, or if the level of the anti-vinculin antibody is not significantly higher than an established control level.   
     
     
         2 . The method of  claim 1 , further comprising selecting a therapy for the gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia if the presence or likely presence of the gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia is determined. 
     
     
         3 . The method of  claim 2 , wherein the therapy is a course of antibiotic therapy. 
     
     
         4 . The method of  claim 2 , wherein the therapy comprises an anti-vinculin antibody neutralizing agent or an anti-vinculin antibody inhibiting agent. 
     
     
         5 . The method of  claim 2 , wherein the therapy comprises an agent to change vinculin from an inactive state to an active state. 
     
     
         6 . The method of  claim 2 , wherein the therapy comprises a vinculin agonist. 
     
     
         7 . The method of  claim 6 , wherein the vinculin agonist is a vinculin activating peptide. 
     
     
         8 . The method of  claim 2 , wherein the therapy comprises a vinculin activator. 
     
     
         9 . The method of  claim 8 , wherein the vinculin activator is talin, f-actin, a-catenin or a combination thereof. 
     
     
         10 . The method of  claim 2 , further comprising administering the therapy. 
     
     
         11 . A system, comprising:
 an isolated biological sample from a subject desiring diagnosis of a gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia; and   an assay for detecting in the biological sample, a presence of an anti-vinculin antibody.   
     
     
         12 . The system of  claim 11 , wherein the assay is an enzyme-linked immunosorbent assay (ELISA), wherein the ELISA comprises using vinculin, SEQ ID NO: 1 or a fragment thereof as a substrate or reagent to bind the anti-vinculin antibody. 
     
     
         13 . A method, comprising:
 providing a biological sample from a subject desiring diagnosis of a gastrointestinal motility disorder, bladder motility disorder, or fibromyalgia;   detecting in the biological same, a presence or a level of an anti-vinculin antibody; and   determining a presence or likely presence of irritable bowel syndrome (IBS) if the presence of the anti-vinculin antibody is detected, if the level of the anti-vinculin antibody is higher than an established control level, or if the level of the anti-vinculin antibody is significantly higher than an established control level, or   determining an presence or likely presence of inflammatory bowel disease (IBD) if an absence of the anti-vinculin antibody is detected, if the level of the anti-vinculin antibody is equal to or lower than an established control level, or if the level of the anti-vinculin antibody is not significantly higher than an established control level.   
     
     
         14 . The method of  claim 13 , further comprising selecting an IBS therapy if IBS is diagnosed, or selecting an IBD therapy if IBD is diagnosed. 
     
     
         15 . The method of  claim 14 , wherein the IBS therapy is a course of antibiotic therapy. 
     
     
         16 . The method of  claim 14 , wherein the IBS therapy comprises an anti-vinculin antibody neutralizing agent or an anti-vinculin antibody inhibiting agent. 
     
     
         17 . The method of  claim 14 , wherein the IBS therapy comprises an agent to change vinculin from an inactive state to an active state. 
     
     
         18 . The method of  claim 14 , wherein the IBS therapy comprises a vinculin agonist. 
     
     
         19 . The method of  claim 18 , wherein the vinculin agonist is a vinculin activating peptide. 
     
     
         20 . The method of  claim 14 , wherein the IBS therapy comprises a vinculin activator. 
     
     
         21 - 27 . (canceled)