Helicobacter Pylori Infection
Conditions
Keywords
HP, UBT, PPI
Brief summary
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
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.
Interventions
DRUGLansoprazole (Lanton)
Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection
DRUGOmeprezole (Losec)
Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection
DRUGPantoprazole(Controloc)
Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection
Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection
Sponsors
Rabin Medical Center
Meridian Bioscience, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | 17 days | 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. |
Countries
Israel
Participant flow
Recruitment details
Two out-patient clinics in hospitals will enroll subjects
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lansoprazole (Lanton) Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days | 29 |
| Omeprazole( Losec) Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days | 62 |
| Pantoprazole (Controloc) Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days | 19 |
| Esomeprazole (Nexium) Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days | 13 |
| Total | 123 |
Baseline characteristics
| Characteristic | Total | Lansoprazole (Lanton) | Omeprazole( Losec) | Pantoprazole (Controloc) | Esomeprazole (Nexium) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 3 Participants | 7 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 26 Participants | 55 Participants | 17 Participants | 9 Participants |
| Age, Continuous | 52.46 years STANDARD_DEVIATION 14.01 | 52.86 years STANDARD_DEVIATION 14.67 | 52.48 years STANDARD_DEVIATION 13.35 | 51.84 years STANDARD_DEVIATION 12.78 | 55.38 years STANDARD_DEVIATION 14.84 |
| H. Pyori Positive | 123 particpants | 29 particpants | 62 particpants | 19 particpants | 13 particpants |
| Region of Enrollment Israel | 123 participants | 29 participants | 62 participants | 19 participants | 13 participants |
| Sex: Female, Male Female | 82 Participants | 20 Participants | 40 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 41 Participants | 9 Participants | 22 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 62 | 0 / 19 | 0 / 13 |
| serious Total, serious adverse events | 0 / 29 | 0 / 62 | 0 / 19 | 0 / 13 |
Outcome results
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.
Time frame: 17 days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole (Lanton) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 3 days of no PPI | 1 participants |
| Lansoprazole (Lanton) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 1 day of no PPI | 2 participants |
| Omeprazole( Losec) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 1 day of no PPI | 4 participants |
| Omeprazole( Losec) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 3 days of no PPI | 3 participants |
| Pantoprazole (Controloc) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 3 days of no PPI | 1 participants |
| Pantoprazole (Controloc) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 1 day of no PPI | 2 participants |
| Esomeprazole (Nexium) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 3 days of no PPI | 0 participants |
| Esomeprazole (Nexium) | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | False negatives (DOB<5) after 1 day of no PPI | 1 participants |