- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00194688
Breath Ammonia Method for H. Pylori Detection: Phase II
Study Overview
Status
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
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Sensitivity and specificity of breath ammonia measurement for H. pylori infection
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Secondary Outcome Measures
Outcome Measure |
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Determination of a dose response relationship for oral urea dose and breath ammonia level.
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Determination of whether breath ammonia measurement allows determination of successful H. pylori treatment.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: David L Putnam, PhD, Pacific Technologies, Inc.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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