Claims for Patent: 4,830,010

Summary for Patent: 4,830,010

Title:	Methods for the diagnosis of gastrointestinal disorders
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.
Inventor(s):	Marshall; Barry J. (Mount Hawthorn 6016, Perth, Western Australia, AU)
Assignee:
Application Number:	07/147,058
Patent 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.