The aim of this study is to assess the change of ammonia exhaled in Helicobacter pylori (HP) positive patients compared with patients that are not HP infected after urea administration. In principle, in this pilot study, the results of Kearney et al…
ID
Source
Brief title
Condition
- Gastrointestinal infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The test variable is the concentration of the exhaled ammonia (ppm). Also the
respiratory ammonia output is determined (micro mol / min).
Secondary outcome
not applicable
Background summary
Breath Tests, which are applied in the diagnosis of Helicobacter pylori
infection, all use the high urease activity of the micro-organism. The usual
breath tests measure the increase in CO2 excretion in expired air after
administration of 13C or 14C labeled urea. At the break-down of the urea,
however, also NH4+ and NH3 in the gaseous phase are released. Only one study
evaluated the measurement of this gas in exhaled air for the diagnosis of
Helicobacter pylori infections in a small group of 13 subjects. Five of them
were infected with Helicobacter pylori (according to a positive 14C-urea breath
test).
Study objective
The aim of this study is to assess the change of ammonia exhaled in
Helicobacter pylori (HP) positive patients compared with patients that are not
HP infected after urea administration. In principle, in this pilot study, the
results of Kearney et al (Dig Dis Sci 2002, 47:2523-2530) are objectified. This
study showed that there was significant increase in ammonia exhalation from
HP-infected (N = 5) patients after urea administration. The non-infected
individuals (N = 9) showed no increase
Study design
The test variable is the concentration of the exhaled ammonia (ppm). Also the
respiratory ammonia output is determined (micro mol / min). Study design: In 30
HP+ and 30 HP non-infected infected patients these 2 variables are determined
for one hour following the administration of 300 mg of urea at t = 0 and the
administration of 500 mg Algeldraat at t = 30 minutes
Study burden and risks
The burden is very low. During the test the patients only have to breath into a
mouthpiece. Also the risk of administration of urea and Algedraat is considered
to be very low.
Zernikelaan 6
9747 AA Groningen
NL
Zernikelaan 6
9747 AA Groningen
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing a diagnostic endoscopy which is based on their dyspeptic symptoms
Exclusion criteria
Patients using a proton pump blocker (PPI) within the preceding 14 days, or an antibiotic in the previous month are excluded from the study. Furthermore, patients are excluded if the extent of erosion of the tractus digestivus justifies immediate medical intervention.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL40399.091.12 |