Breath Ammonia Method for H. Pylori Detection: Phase II

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

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)