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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

January 2, 2008

Start Date ^†

March 2003

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00194688 on ClinicalTrials.gov Archive Site

Current 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.

Original 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.

Descriptive Information

Brief Title ^†

Breath Ammonia Method for H. Pylori Detection: Phase II

Official Title ^†

Breath Ammonia Method for H. Pylori Detection: Phase II

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Helicobacter Infections

Intervention ^†

Drug: H. pylori treatment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

278

Completion Date

June 2005

Primary Completion Date

Eligibility 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)

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00194688

Responsible Party

David Kearney, MD, University of Washington

Secondary IDs ^††

2 R44 DK 55935-02

Study Sponsor ^†

University of Washington

Collaborators ^††

National Institutes of Health (NIH)

Investigators ^†

Study Director:

David L Putnam, PhD

Pacific Technologies, Inc.

Information Provided By

University of Washington

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.