# US 10,501,771 B2 · Methods and uses for metabolic profiling for Clostridium difficile infection

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- Number: US 10,501,771 B2
- Document ID: US10501771B2
- Status: Granted
- Kind: B2
- Application number: 14/357,027
- Filed: 2012-11-08
- Published: 2014-10-02
- Granted: 2019-12-10
- Earliest claimed: 2011-11-08
- Assignees: Board of Regents, The University of Texas System
- Applicants: The Board of Regents of the University of Texas System
- Inventors: Tor Savidge; Sara Dann
- Web page: https://patentgrep.com/patent/US10501771B2

## CPC

- C12Q 1/04: Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q1/6897 takes precedence)}
- G01N 33/56905: {Protozoa}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2333/33: from Clostridium (G)
- G01N 2560/00: Chemical aspects of mass spectrometric analysis of biological material
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Embodiments include methods for generating a metabolite profile of a stool sample and methods of assessing the status of a subject using the metabolic profile derived from a stool sample.

## Claims

### Claim 1

A method of treating a subject having a Clostridium difficile infection (CDI) comprising:
measuring levels of gamma-aminobutyrate (GABA), ammonia, or GABA and ammonia, in a stool sample from a subject; and
administering a treatment for CDI to the subject if the levels of the one or more biomarkers are elevated compared to a reference level.

### Claim 2 (depends on 1)

The method of claim 1, wherein the treatment of CDI includes administering metronidazole, vancomycin, fidaxomicin, rifampicin, rifaximin, nitazoxanide, rifabutin, or combinations thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein the treatment of CDI includes administering a probiotic therapy.

### Claim 4 (depends on 1)

The method of claim 1, wherein the treatment of CDI includes administering phytic acid or derivatives thereof.

### Claim 5

A method of treating a subject having a recurrent Clostridium difficile infection (CDI) comprising:
distinguishing a subject having recurrent Clostridium difficile infection from a subject having a non-recurrent Clostridium difficile infection comprising measuring levels of one or more biomarkers selected from ammonia or gamma-aminobutyrate (GABA) in a stool sample and identifying a subject having a recurrent CDI if one or more biomarkers are elevated more than 200% compared to a non-infected control level; and
administering a treatment for CDI to the subjects identified as having recurrent CDI.

### Claim 6 (depends on 5)

The method of claim 5, wherein the biological sample is a stool sample.