Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194688
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2005-09-13
Brief Title:
Breath Ammonia Method for H Pylori Detection Phase II
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Breath Ammonia Method for H Pylori Detection Phase II
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to evaluate the utility of a breath ammonia sensing device In this study we will assess the effect of H pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H pylori positive patients compared to H pylori negative patients
Detailed Description:
Healthy volunteers will undergo testing for H pylori infection using a 14-C urea breath test and the results will be compared to an experimental ammonia breath test The breath sample will be collected by an investigational device that the patient will be exposed to consisting of a plastic mouth-piece which is attached to a T-tubing section having a side-arm port through which a fiberoptic ammonia sensor is inserted inside the tube To meet the Phase II specific aim the scope of the clinical trials is expanded addressing the following specific objectives
Test refinements of the sensing system hardware software breath test device
Determine whether a urea dose-response effect exists following urea ingestion
Define the optimal cutoff values for expired breath ammonia to allow optimal discrimination of H pylori infected vs uninfected persons
Determine the appropriate time interval for breath ammonia testing following urea ingestion
Determine whether there is a change in breath ammonia level after H pylori treatment
Test refinements of the sensing system hardware software breath test device
Determine whether a urea dose-response effect exists following urea ingestion
Define the optimal cutoff values for expired breath ammonia to allow optimal discrimination of H pylori infected vs uninfected persons
Determine the appropriate time interval for breath ammonia testing following urea ingestion
Determine whether there is a change in breath ammonia level after H pylori treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R44DK055935-02 | NIH | None | httpsreporternihgovquickSearch2R44DK055935-02 |