Breath Ammonia Method for H. Pylori Detection: Phase II
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
|Official Title:||Breath Ammonia Method for H. Pylori Detection: Phase II|
- Sensitivity and specificity of breath ammonia measurement for H. pylori infection
- Determination of a dose response relationship for oral urea dose and breath ammonia level.
- Determination of whether breath ammonia measurement allows determination of successful H. pylori treatment.
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||June 2005|
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.
|United States, Washington|
|VA Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|Study Director:||David L Putnam, PhD||Pacific Technologies, Inc.|