Breath Ammonia Method for H. Pylori Detection: Phase II

Completed · Phase 2

Conditions studied: Helicobacter Infections

In brief

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.

Key facts

Study ID

NCT00194688

Run by

University of Washington

People needed

278

Starts

2003-03-01

Expected to finish

2005-06-01

Last updated by the study team

2008-01-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult volunteers not meeting exclusion criteria

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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