The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.
This study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 15 days and subjects eligibility will be evaluated after informed consent signature. Urea breath test (UBT) will be performed in addition to routine baseline evaluations (physical, lab test, etc). Treatment: subjects will be treated for 10 days. A "confirmation of eligibility" visit will take place on Day 0 and an "end-of-treatment" visit will take place between days 9-14. Follow-up: approximately one month post-treatment, eradication of H. pylori will be confirmed through UBT
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Omeprazole 20 mg twice daily, in combination with bismuth subcitrate potassium (40 mg), metronidazole 125 mg and tetracycline 125 mg HCl. All patients must take 6 capsules of Pylera, in addition to 1 omeprazole twice daily
University of Michigan Health System
Ann Arbor, Michigan, United States
Aurora Health Care
Milwaukee, Wisconsin, United States
McMaster University Medical Center, Division of Gastroenterology
Hamilton, Ontario, Canada
H. pylori status confirmed by Urea Breath Test
Time frame: at 6 and 10 weeks following treatment
Tolerability
Time frame: at the end of treatment, one and two months post-treatment
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