Methods for the diagnosis of gastrointestinal disorders

• US 4,830,010 A
• Filed: 01/22/1988
• Issued: 05/16/1989
• Est. Priority Date: 04/04/1986
• Status: Expired due to Term

• Current Assignee: Medquest Pty Limited
• Original Assignee: Barry J. Marshall
• Inventors: Marshall, Barry J.
• Primary Examiner(s): Coven, Edward M.
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/147,058
• Time in Patent Office: 480 Days
• Field of Search: 128/630, 128/659, 128/719, 424/1.1, 424/9, 436/804, 436/811, 356/51
• US Class Current: 600/300
• 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
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

Methods for the diagnosis of gastrointestinal disorders in human or lower animal subjects comprising the steps of administering to said subject a safe and effective amount of urea and analyzing the breath of said subject for the presence of carbon dioxide or ammonia products of the hydrolysis of said urea, wherein the presence of said hydrolysis products is a positive indication of a gastrointestinal disorder in said subject. Preferably the administered urea contains isotope-labelled nitrogen or carbon.

Claims

1. A method for the diagnosis in a human or lower animal subject of a gastrointestinal disorder of the upper gastrointestinal tract caused or mediated by the bacteria Campylobacter pyloridis, said method comprising the steps of administering to said subject a safe and effective amount of isotope-labeled urea, and analyzing the breath of said subject for the presence of isotope-labeled carbon dioxide, isotope-labeled ammonia, or both hydrolysis products, wherein the presence of either or both said hydrolysis products is a positive indication of said gstrointestinal disorder in said subject.

2. A method for the diagnosis in a human or lower animal subject of a gastrointestinal disorder of the upper gastrointestinal tract caused or mediated by bacteria which result in the gastric materials of the human or lower animal to contain relatively large quantities of urease, said method comprising the steps of administering to said subject a safe and effective amount of isotope-labeled urea, and analyzing the breath of said subject for the presence of isotope-labeled carbon dioxide, isotope-labeled ammonia, or both hydrolysis products, wherein the presence of either or both said hydrolysis products is a positive indication of said gastrointestinal disorder in said subject.

3. A method for the diagnosis of a gastrointestinal disorder of the upper gastrointestinal tract caused or mediated by bacteria resulting in the gastric materials containing relatively large quantities of urease in a human or lower animal subject, according to claim 2 wherein said analyzing step involves analyzing the breath of said subject for the presence of isotope-labeled carbon dioxide hydrolysis product of said isotope-labeled urea.

4. The method for the diagnosis of a gastrointestinal disorder of the upper gastrointestinal tract caused or mediated by bacteria resulting in the gastric materials containing relatively large quantities of urease in a human or lower animal subject, according to claim 3, wherein said urea is isotope-labeled with carbon-14 isotope.

5. A method for the diagnosis of a gastrointestinal disorder of the upper gastrointestinal tract caused or mediated by bacteria resulting in the gastric materials containing relatively large quantities of urease in a human or lower animal subject, according to claim 3, wherein said urea is isotope-labeled with carbon-13 isotope.

6. A method for the diagnosis of a gastrointestinal disorder of the upper gastrointestinal tract caused or mediated by bacteria resulting in the gastric materials containing relatively large quantities of urease in a human or lower animal subject, according to claim 2, wherein said analyzing step involves analyzing the breath of said subject for the presence of isotope-labeled ammonia hydrolysis product of said isotope-labeled urea.

7. A method for the diagnosis of a gastrointestinal disorder of the upper gastrointestinal tract caused or mediated by bacteria resulting in the gastric materials containing relatively large quantities of urease in a human or lower animal subject, according to claim 6, wherein said urea is isotope-labeled with nitrogen-15 isotope.