Helicobacter Infections Clinical Trial
Official title:
Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given X 10 Days With Omeprazole in Eradication of Helicobacter Pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given X 7 Days
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
The study will include three phases: screening, treatment and follow-up. Screening: this
phase will last a maximum of 30 days and subjects eligibility will be evaluated after
informed consent signature. Endoscopy and Urea Breath test will be performed in addition to
the baseline routine evaluations.
Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera
will be treated for 10 days. A randomization visit will take place on Day 0 and an
end-of-treatment visit will take place between day 8 and 14.
Follow-up: includes two visits. approximately one and two months post-treatment. Eradication
of H. Pylori will be confirmed through UBT, and resistance will be evaluated in case of
treatment failure. These subjects will undergo an endoscopy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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