IP Library Granted Patent US 7,736,622
Granted Patent B2
US 7,736,622 · App. 11/348,995 · Granted Jun 15, 2010

Methods of diagnosing small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions

Assignee: Cedars-Sinai Medical Center
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Quick Facts
Patent No.
US 7,736,622
App. No.
11/348,995
Granted
Jun 15, 2010
Kind
B2
Abstract

Disclosed is a method of treating small intestinal bacterial overgrowth (SIBO) or a SIBO-caused condition in a human subject. SIBO-caused conditions include irritable bowel syndrome, fibromyalgia, chronic pelvic pain syndrome, chronic fatigue syndrome, depression, impaired mentation, impaired memory, halitosis, tinnitus, sugar craving, autism, attention deficit/hyperactivity disorder, drug sensitivity, an autoimmune disease, and Crohn's disease. Also disclosed are a method of screening for the abnormally likely presence of SIBO in a human subject and a method of detecting SIBO in a human subject. A method of determining the relative severity of SIBO or a SIBO-caused condition in a human subject, in whom small intestinal bacterial overgrowth (SIBO) has been detected, is also disclosed.

Claims (32)

1. A method of detecting small intestinal bacterial overgrowth (SIBO) in a human subject, comprising:

detecting relative amounts of methane, hydrogen, and at least one sulfur-containing gas in a gas mixture exhaled by said human subject, after said human subject has ingested a controlled quantity of an isotope-labeled sugar, a sugar that is poorly digestible by a human or an isotope-labeled sugar that is poorly digestible by a human, said gas mixture being at least partially produced by the intestinal microflora of said human subject; and

corroborating the relative amounts of methane, hydrogen, and at least one sulfur-containing gas with a presence or absence of SIBO, wherein

an amount of methane, hydrogen, or at least one sulfur-containing gas that is above a normal range for a healthy human subject for the methane, hydrogen, and/or at least one sulfur-containing gas is corroborated with the presence of SIBO,

an amount of methane and/or hydrogen that is less than an amount of the at least one sulfur-containing gas is corroborated with the presence of SIBO,

an amount of methane, hydrogen, and at least one sulfur-containing gas that is below the normal range for a healthy human subject for methane, hydrogen, and at least one sulfur-containing gas is corroborated with the absence of SIBO, or

an absence of methane, hydrogen, or at least one sulfur-containing gas is corroborated with the absence of SIBO.

2. The method of claim 1 , wherein the isotope-labeled sugar, the sugar that is poorly digestible by a human, or the isotope-labeled sugar that is poorly digestible by a human is glucose, lactose, sucrose, lactulose or xylose.

3. The method of claim 1 , wherein detecting the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in the exhaled gas mixture is accomplished by gas chromatography and/or a radiation detection system.

4. The method of claim 1 , wherein detecting the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in the exhaled gas mixture is accomplished by mass spectrometry.

5. The method of claim 1 , wherein detecting the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in the exhaled gas mixture is accomplished using thin-layer chromatography, high pressure liquid chromatography, an electrochemical voltametric sensor, or a polarographic cell.

6. The method of claim 1 , wherein the at least one sulfur-containing gas is hydrogen sulfide or a sulfhydryl compound.

7. The method of claim 1 , wherein the at least one sulfur-containing gas is methanethiol, dimethylsulfide, dimethyl disulfide, an allyl methyl sulfide, an allyl methyl disulfide, an allyl disulfide, an allyl mercaptan, or a methylmercaptan.

8. A method of determining the relative severity of SIBO or a SIBO caused condition in a human subject in whom SIBO has been detected, comprising: detecting in the subject by suitable detection means, the presence of SIBO, or detecting with said means the absence of SIBO; and, if the presence of SIBO is detected in the subject, detecting in the subject by suitable detection means a relative level of intestinal permeability, abnormally high intestinal permeability indicating a relatively severe SIBO or SIBO-caused condition in the subject.

9. A kit for the diagnosis of SIBO or a SIBO-caused condition, comprising: at least one breath sampling container, a pre-measured amount of an isotope-labeled sugar, a sugar that is poorly digestible by a human or an isotope-labeled sugar that is poorly digestible by a human, and instructions for a user in detecting the presence or absence of SIBO by determining the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in a gas mixture exhaled by said human subject, after said human subject has ingested a controlled quantity of the isotope-labeled sugar, the sugar that is poorly digestible by the human or the isotope-labeled sugar that is poorly digestible by the human.

10. The kit of claim 9 , wherein the pre-measured isotope-labeled sugar, sugar that is poorly digestible by the human or isotope-labeled sugar that is poorly digestible by the human is glucose, lactose, sucrose, lactulose or xylose.

11. The kit of claim 9 , further comprising standardized samples of methane, hydrogen, and at least one sulfur-containing gas.

12. The kit of claim 9 , wherein the at least one sulfur-containing gas is hydrogen sulfide or a sulfhydryl compound.

13. The kit of claim 9 , wherein the at least one sulfur-containing gas is methanethiol, dimethylsulfide, dimethyl disulfide, an allyl methyl sulfide, an allyl methyl disulfide, an allyl disulfide, an allyl mercaptan, or a methylmercaptan.

14. A method for detecting small intestinal bacterial overgrowth (SIBO) in a human subject by corroborating the relative amounts of methane, hydrogen, and at least one sulfur-containing gas with the presence or absence of SIBO, said method comprising:

administering a controlled quantity of an isotope-labeled sugar, a sugar that is poorly digestible by a human or an isotope-labeled sugar that is poorly digestible by a human, to produce a gas mixture, said gas mixture being at least partially produced by the intestinal microflora of said human subject; and

detecting the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in said gas mixture exhaled by said human subject, wherein

i) an amount of methane, hydrogen, or at least one sulfur-containing gas that is above a normal range for a healthy human subject for the methane, hydrogen, and/or at least one sulfur-containing gas is corroborated with the presence of SIBO;

ii) an amount of methane and/or hydrogen that is less than an amount of the at least one sulfur-containing gas is corroborated with the presence of SIBO;

iii) an amount of methane, hydrogen, and at least one sulfur-containing gas that is below the normal range for a healthy human subject for methane, hydrogen, and at least one sulfur-containing gas is corroborated with the absence of SIBO; or

iv) an absence of methane, hydrogen, or at least one sulfur-containing gas is corroborated with the absence of SIBO.

15. The method of claim 14 , wherein the isotope-labeled sugar, the sugar that is poorly digestible by a human, or the isotope-labeled sugar that is poorly digestible by a human is glucose, lactose, sucrose, lactulose or xylose.

16. The method of claim 14 , wherein detecting the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in the exhaled gas mixture is accomplished by gas chromatography and/or a radiation detection system.

17. The method of claim 14 , wherein detecting the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in the exhaled gas mixture is accomplished by mass spectrometry.

18. The method of claim 14 , wherein detecting the relative amounts of methane, hydrogen, and at least one sulfur-containing gas in the exhaled gas mixture is accomplished using thin-layer chromatography, high pressure liquid chromatography, an electrochemical voltametric sensor, or a polarographic cell.

19. The method of claim 14 , wherein the at least one sulfur-containing gas is hydrogen sulfide or a sulfhydryl compound.

20. The method of claim 14 , wherein the at least one sulfur-containing gas is methanethiol, dimethylsulfide, dimethyl disulfide, an allyl methyl sulfide, an allyl methyl disulfide, an allyl disulfide, an allyl mercaptan, or a methylmercaptan.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jul 13, 2016
From: CEDARS-SINAI MEDICAL CENTER
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 039323/0903 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 7, 2006
From: LIN, HENRY C.; PIMENTEL, MARK
To: CEDARS-SINAI MEDICAL CENTER
Reel/Frame 017560/0246 →
Continuity (5)
Division 0983779700 · Apr 17, 2001
Continuation In Part 0954611900 · Apr 10, 2000
Continuation In Part 0937414200 · Aug 11, 1999
Continuation In Part 0937414300 · Aug 11, 1999
Related Publication 20060147496A1 · Jul 6, 2006