Breath Ammonia Method for H. Pylori Detection: Phase II

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Breath Ammonia Method for H. Pylori Detection: Phase II

Conditions
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Helicobacter Infections

Intervention / Treatment
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* Drug: H. pylori treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: H. pylori treatment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of breath ammonia measurement for H. pylori infection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of a dose response relationship for oral urea dose and breath ammonia level. |  |  | 
| Determination of whether breath ammonia measurement allows determination of successful H. pylori treatment. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ammonia