Breath Ammonia Method for H. Pylori Detection: Phase II

January 2, 2008 updated by: University of Washington
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

278

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)

Investigators

  • Study Director: David L Putnam, PhD, Pacific Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 2, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-8470-V 04
  • 2R44DK055935-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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