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

• US 8,388,935 B2
• Filed: 12/09/2011
• Issued: 03/05/2013
• Est. Priority Date: 08/11/1999
• Status: Expired due to Term

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Lin, Henry C., Pimentel, Mark
• Primary Examiner(s): Swartz, Rodney P.
• Application Number:
  US13/315,671
• Publication Number:
  US 20120263790A1
• Time in Patent Office: 452 Days
• Field of Search: 424/9.1, 424/9.2, 424/116, 424/278.1, 424/439, 426/5, 426/71, 426/658, 426/800, 426/801, 435/4, 435/29
• US Class Current: 424/9.2
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• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• 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 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
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• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/201 having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 31/4184 condensed with carbocyclic rings, e.g. benzimidazoles
• CPC Class Codes: A61K 31/424 condensed with heterocyclic ring systems, e.g. clavulanic acid
• CPC Class Codes: A61K 31/43 Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula , e.g. penicillins, penems
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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• CPC Class Codes: A61K 49/0004 : Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: A61K 51/1206 : Administration of radioactive gases, aerosols or breath tests
• CPC Class Codes: A61K 9/0053 : Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
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• CPC Class Codes: G01N 2333/70571 : for neuromediators, e.g. serotonin receptor, dopamine receptor
• CPC Class Codes: G01N 2800/06 : Gastro-intestinal diseases
• CPC Class Codes: G01N 33/497 : of gaseous biological material, e.g. breath
• CPC Class Codes: G01N 33/6893 : related to diseases not provided for elsewhere
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• CPC Class Codes: Y10T 436/22 : Hydrogen, per se

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

1. A method of treating or reducing the recurrence of small intestinal bacterial overgrowth (SIBO) or a SIBO-caused condition in a human subject, comprising:

providing a pharmaceutically acceptable composition comprising a serotonin receptor agonist; and

administering the pharmaceutically acceptable composition to said human subject to treat or reduce the recurrence of small intestinal bacterial overgrowth (SIBO) or the SIBO-caused condition.

2. The method of claim 1, wherein the SIBO-caused condition is selected from the group consisting of 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, autoimmune disease, and Crohn'"'"'s disease.

3. The method of claim 2, wherein the autoimmune disease is systemic lupus erythematous or multiple sclerosis.

4. The method of claim 1, wherein the SIBO-caused condition is irritable bowel syndrome.

5. The method of claim 1, wherein the serotonin receptor agonist is selected from the group consisting of prucalopride, HTF-919, R-093877, 2-[1(4-Piperonyl)piperazinyl]benzothiazole, 1-(4-Amino-5-chloro-2-methoxyphenyl)-3-[1-butyl-4-piperidinyl]-1-propanone, 1-(4-Amino-5-chloro-2-methoxyphenyl)-3-[1-2-methylsulphonylamino)ethyl-4-piperidinyl]-1-propanone, and combinations thereof.

6. The method of claim 1, wherein the serotonin receptor agonist is prucalopride.

7. The method of claim 1, wherein the pharmaceutically acceptable composition is administered by an oral or enteral delivery route.

8. The method of claim 7, wherein the oral delivery route is by ingestion of coated or uncoated microspheres or particles, of a dispersible powder or granule formulation, of a suspension, emulsion, solution, syrup, or elixir, or of a coated or uncoated tablet, troche, capsule, caplet, or lozenge.

9. A method of treating or reducing the recurrence of irritable bowel syndrome in a human subject, comprising:

providing a pharmaceutically acceptable composition comprising prucalopride; and

administering the pharmaceutically acceptable composition to said human subject to treat or reduce the recurrence of irritable bowel syndrome.

10. The method of claim 9, wherein the pharmaceutically acceptable composition is administered by an oral or enteral delivery route.

11. The method of claim 10, wherein the oral delivery route is by ingestion of coated or uncoated microspheres or particles, of a dispersible powder or granule formulation, of a suspension, emulsion, solution, syrup, or elixir, or of a coated or uncoated tablet, troche, capsule, caplet, or lozenge.

12. A method of treating or reducing the recurrence of small intestinal bacterial overgrowth (SIBO) in a human subject, comprising:

providing a pharmaceutically acceptable composition comprising a serotonin receptor agonist; and

administering the pharmaceutically acceptable composition to said human subject to treat or reduce the recurrence of small intestinal bacterial overgrowth (SIBO).

13. The method of claim 12, wherein the serotonin receptor agonist is selected from the group consisting of prucalopride, HTF-919, R-093877, 2-[1-(4-Piperonyl)piperazinyl]benzothiazole, 1-(4-Amino-5-chloro-2-methoxyphenyl)-3-[1-butyl-4-piperidinyl]-1-propanone, 1-(4-Amino-5-chloro-2-methoxyphenyl)-3-[1-2-methylsulphonylamino)ethyl-4-piperidinyl]-1-propanone, and combinations thereof.

14. The method of claim 12, wherein the serotonin receptor agonist is prucalopride.

15. The method of claim 12, wherein the pharmaceutically acceptable composition is administered by an oral or enteral delivery route.

16. The method of claim 15, wherein the oral delivery route is by ingestion of coated or uncoated microspheres or particles, of a dispersible powder or granule formulation, of a suspension, emulsion, solution, syrup, or elixir, or of a coated or uncoated tablet, troche, capsule, caplet, or lozenge.