IP Library Granted Patent US 9,885,089
Granted Patent B2
US 9,885,089 · App. 14/383,188 · Granted Feb 6, 2018

Flagellum and anti-flagellum antibody levels in samples as a diagnostic biomarker and therapeutic target for metabolic syndrome

Inventors: Ruth E. Ley (Ithaca, NY); Tyler Cullender (Ithaca, NY)
Assignee: CORNELL UNIVERSITY
C12Q1/6897A61K39/40A61K45/06C07K16/12G01N33/6893A61K2039/505G01N2333/195G01N2800/042
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Quick Facts
Patent No.
US 9,885,089
App. No.
14/383,188
Granted
Feb 6, 2018
Kind
B2
Abstract

High levels of bacterial flagella in a sample such as a gastrointestinal sample and/or low levels of anti-flagella antibodies serve as an indication for metabolic syndrome (such as insulin resistance, hypertension, elevated cholesterol, increased risk for blood clotting, and obesity) with highest levels of adiposity. An intervention that reduces the level and/or activity of flagella in the gastrointestinal tract can mitigate the severity of metabolic syndrome or in protecting against the development of metabolic syndrome.

Claims (16)

1. A method of measuring the level of flagellin comprising:

obtaining a gastrointestinal (GI) tract sample of an individual;

detecting the level of flagellin in the sample, wherein the level of flagellin is detected by a cell-based assay that uses a mammalian cell expressing Toll-like receptor 5 (TLR5) or at least one receptor of the NLRC4 inflammasome; and

measuring the level of the flagellin in the sample in comparison with a control level of flagellin in a GI tract sample of a normal healthy individual.

2. The method of claim 1 , wherein the cell comprises a reporter gene whose expression is induced upon binding of the TLR5 or the at least one receptor of the NLRC4 inflammasome with the flagellin and leads to the generation of a detectable signal.

3. The method of claim 2 , wherein the reporter gene is placed under the control of a promoter inducible upon the binding of the TLR5 or the at least one receptor of the NLRC4 inflammasome with the flagellin.

4. The method of claim 1 , wherein an increased level of the flagellin in the GI tract sample of the individual compared to the control level is indicative of the presence of metabolic syndrome in the individual.

5. The method of claim 1 , wherein said sample is selected from a fecal, intestinal, mucosal or oral sample.

6. The method of claim 1 , wherein said cell is a mammalian fibroblast cell line.

7. The method of claim 3 , wherein said promoter comprises an NF-κB response element, a capsase-1 response element, or an NLRC4 inflammasome response element.

8. The method of claim 2 , wherein the reporter gene encodes an enzyme.

9. The method of claim 2 , wherein the reporter gene encodes a fluorescent protein.

10. The method of claim 2 , wherein the cell-based assay comprises the step of:

contacting the cell with the GI sample to form a cell-sample mixture;

incubating the cell-sample mixture to allow binding of the flagellin in the sample to the TLR5 or the at least one receptor of the NLRC4 inflammasome expressed by the cell, thereby inducing the expression of the reporter gene; and

detecting the expression of the reporter gene.

Assignments (3)
CONFIRMATORY LICENSE Recorded Mar 23, 2018
From: CORNELL UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 045689/0144 →
CONFIRMATORY LICENSE Recorded Oct 2, 2017
From: CORNELL UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 044096/0182 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 5, 2014
From: LEY, RUTH E.; CULLENDER, TYLER
To: CORNELL UNIVERSITY
Reel/Frame 033675/0623 →
Continuity (2)
Provisional Application 61606522 · Mar 5, 2012
Related Publication 20150050293A1 · Feb 19, 2015