Breath Ammonia Method for H. Pylori Detection: Phase II

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Helicobacter Infections

Clinical Trial Details

NCT number	NCT00194688
Study type	Interventional
Source	University of Washington
Contact
Status	Completed
Phase	Phase 2
Start date	March 2003
Completion date	June 2005

View Details

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