Breath Ammonia Method for H. Pylori Detection: Phase II - Full Text View

Sponsors and Collaborators:	University of Washington National Institutes of Health (NIH)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00194688

Purpose

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.

Condition	Intervention	Phase
Helicobacter Infections	Drug: H. pylori treatment	Phase II

Drug Information available for: Ammonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Breath Ammonia Method for H. Pylori Detection: Phase II

Further study details as provided by University of Washington:

Primary Outcome Measures:

Sensitivity and specificity of breath ammonia measurement for H. pylori infection

Secondary Outcome Measures:

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.

Estimated Enrollment:	278
Study Start Date:	March 2003
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult volunteers not meeting exclusion criteria

Exclusion Criteria:

Known cirrhosis of the liver
Renal insufficiency (BUN greater than 40 mg/dl, Creatinine greater than 2.0 mg/dl).
Prior gastric resection
Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second less than 1.5 L)
Patients unwilling or unable to discontinue proton pump inhibitors for 2 weeks prior to scheduled 14C or non-isotopic urea breath testing
Patients who have received antibiotics or bismuth within the preceding month.
Patients unwilling or unable to give informed consent
Pregnant women (14C urea breath test is not approved for use in pregnant women)
Age less than 21 years (14C urea breath test is not approved for use in children)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194688

Locations

United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

Investigators

Study Director:

David L Putnam, PhD

Pacific Technologies, Inc.

More Information

Responsible Party:	University of Washington ( David Kearney, MD )
Study ID Numbers:	01-8470-V 04, 2 R44 DK 55935-02
Study First Received:	September 13, 2005
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00194688
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

ammonia

Study placed in the following topic categories:

Bacterial Infections
Helicobacter Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009