Breath test for the diagnosis of Helicobacter pylori infection in the gastrointestinal tract

• US 6,067,989 A
• Filed: 02/26/1997
• Issued: 05/30/2000
• Est. Priority Date: 02/26/1997
• Status: Expired due to Term

• Current Assignee: Exalenz Bioscience, Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Oridion Medical Ltd (Medtronic Plc)
• Inventors: Katzman, Daniel E.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): WEISS JR, JOSEPH
• Application Number:
  US08/805,415
• Time in Patent Office: 1,189 Days
• Field of Search: 128/898, 60/529, 60/532, 422/84, 73/23.3
• US Class Current: 128/898
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence

Abstract

A breath test for diagnosing the presence of Helicobacter pylori in a subject is described. The method of diagnosing Helicobacter pylori is performed as follows. First, a safe and effective amount of urea, preferably appropriately labelled, is administered to the subject. Second, a plurality of the exhaled breaths of the subject is analyzed to detect the concentration of a cleavage product or products, produced when urease cleaves the substrate. The measured concentrations are then fitted to a curve, and the derivative is then calculated, to indicate the presence or absence of Helicobacter pylori infection in the subject.

Claims

1. A method for the diagnosis of Helicobacter Pylori in the gastrointestinal tract of a subject, comprising the steps of:

(a) administering isotope-labeled urea to the subject, said isotope-labeled urea being cleavable by urease to form a cleavage product;

(b) having said subject exhale repeatedly into analyzing equipment;

(c) analyzing a plurality of exhaled breaths of the subject substantially in real time while the subject'"'"'s exhalation contains the cleavage product, if present, to determine a plurality of concentrations of said cleavage product; and

(d) analyzing said plurality of concentrations to indicate Helicobacter Pylori activity in the gastrointestinal tract of said subject, wherein the step of analyzing said exhaled breath of the subject is repeated substantially continuously until a predetermined accuracy for analyzing said plurality of concentrations is reached.

2. The method of claim 1, wherein the step of analyzing said exhaled breath of the subject is repeated substantially continuously until a predetermined time period has elapsed.

3. The method of claim 1, wherein said exhaled breath of the subject is analyzed by an infrared spectrometer.

4. The method of claim 1, wherein said cleavage product is carbon dioxide.

6. The method of claim 1, wherein said cleavage product is ammonia.

7. The method of claim 6, wherein said ammonia is nitrogen-15 isotopically-labelled.

8. The method of claim 1, wherein the step of using said plurality of concentrations is performed by fitting said concentrations to a curve.

9. The method of claim 8, wherein said curve is analyzed by inspecting its derivative.

10. The method of claim 2, and wherein said particular time period is such that said concentrations are still increasing before said predetermined time period has elapsed.

5. The method of claim;

wherein said carbon dioxide is carbon-13 isotopically-labelled.