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| Name | Class |
|---|---|
| Rabin Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole (Lanton) | Active Comparator | Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning |
|
| Omeprazole (Losec) | Active Comparator | Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning |
|
| Pantoprazole (Controloc) | Active Comparator | Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning |
|
| Esomeprazole(Nexium) | Active Comparator | Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole (Lanton) | Drug | Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haim Shirin, MD | Sharon Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12526935 | Result | Shirin H, Frenkel D, Shevah O, Levine A, Bruck R, Moss SF, Niv Y, Avni Y. Effect of proton pump inhibitors on the continuous real time (13)C-urea breath test. Am J Gastroenterol. 2003 Jan;98(1):46-50. doi: 10.1111/j.1572-0241.2003.07187.x. |
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Size of arms varied due availability of PPI (proton pump inhibitors) and desire to gather more data in most common PPIs.Ethics committees approved additional recruitment.
Two out-patient clinics in hospitals will enroll subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole (Lanton) | Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days |
| FG001 | Omeprazole( Losec) | Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days |
| FG002 | Pantoprazole (Controloc) | Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days |
| FG003 | Esomeprazole (Nexium) | Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lansoprazole (Lanton) | Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days |
| BG001 | Omeprazole( Losec) | Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study. | Posted | Number | participants | 17 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lansoprazole (Lanton) | Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days |
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It was hard to get people to agree to return for multiple tests within a few days, so the enrollment was difficult
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haim Shirin | Sharon Hospital | 0097239372231 | haims3@clalit.org.il |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D009853 | Omeprazole |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Omeprezole (Losec) | Drug | Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection |
|
|
| Pantoprazole(Controloc) | Drug | Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection |
|
|
| Esomeprazole (Nexium) | Drug | Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection |
|
|
| BG002 | Pantoprazole (Controloc) | Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days |
| BG003 | Esomeprazole (Nexium) | Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| H. Pyori Positive | Basline particpants include all those with suspected H.pylori infection that are tested with the FDA cleared BreathID 13C urea breath test and are found to be positive, that is DOB (delta over baseline) >=5 | Number | particpants |
|
| OG001 | Omeprazole( Losec) | Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days |
| OG002 | Pantoprazole (Controloc) | Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days |
| OG003 | Esomeprazole (Nexium) | Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Omeprazole( Losec) | Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days | 0 | 62 | 0 | 62 |
| EG002 | Pantoprazole (Controloc) | Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days | 0 | 19 | 0 | 19 |
| EG003 | Esomeprazole (Nexium) | Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days | 0 | 13 | 0 | 13 |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |