Status:
COMPLETED
Breath Ammonia Method for H. Pylori Detection: Phase II
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Helicobacter Infections
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 cha...
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 collec...
Eligibility Criteria
Inclusion
- Adult volunteers not meeting exclusion criteria
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00194688
Start Date
March 1 2003
End Date
June 1 2005
Last Update
January 11 2008
Active Locations (1)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108