Breath Ammonia Method for H. Pylori Detection: Phase II

Helicobacter Infections Clinical Trial

Official title:

Breath Ammonia Method for H. Pylori Detection: Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194688
• Other study ID #: 01-8470-V 04
• Secondary ID: 2R44DK055935-02
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 2, 2008
• Start date: March 2003
• Est. completion date: June 2005

Study information

• Verified date: January 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 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

Intervention

Drug:
• H. pylori treatment

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of breath ammonia measurement for H. pylori infection
Secondary	Determination of a dose response relationship for oral urea dose and breath ammonia level.
Secondary	Determination of whether breath ammonia measurement allows determination of successful H. pylori treatment.