13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

Study Overview
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Brief Summary
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Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.

Detailed Description
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Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests. Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded. Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.

Official Title
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The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Lansoprazole (Lanton)
* Drug: Omeprezole (Losec)
* Drug: Pantoprazole(Controloc)
* Drug: Esomeprazole (Nexium)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with H.pylori infection. Exclusion Criteria: Pregnancy, Nursing, Antibiotic, bismuth or PPI treatment 2 weeks prior to trial, Known sensitivity to Urea or citrica.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lansoprazole (Lanton)<br>Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning | Drug: Lansoprazole (Lanton)<br>* Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection<br>* Other names: Lanton;|
| Active Comparator: Omeprazole (Losec)<br>Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning | Drug: Omeprezole (Losec)<br>* Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection<br>* Other names: Losec;|
| Active Comparator: Pantoprazole (Controloc)<br>Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning | Drug: Pantoprazole(Controloc)<br>* Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection<br>* Other names: Controloc;|
| Active Comparator: Esomeprazole(Nexium)<br>Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning | Drug: Esomeprazole (Nexium)<br>* Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy. | 17 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HP, UBT, PPI