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Study aim
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Comparison of two quadruple diets of amoxicillin, bismuth, levofloxacin and pantoprazole versus amoxicillin, clarithromycin, bismuth, pantoprazole to eradicate Helicobacter pylori
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 196 patients. Software Random Allocation software will be used for randomization
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Settings and conduct
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This study is an interventional study and the study population is patients infected with Helicobacter pylori referred to a private clinic in Rasht. Patients who go to the clinic with a complaint of dyspepsia, reflux and meet the inclusion criteria will be admitted to the study after confirmation of consent. patients will be randomly divided into 88 groups. The first group will be treated with clarithromycin, pantoprazole, bismuth tablets , and amoxicillin. The second group will receive a treatment regimen containing levofloxacin , pantoprazole, bismuth tablets and amoxicillin. Patients who have completed treatment will have another urease breath test to check for eradication of Helicobacter pylori 4 weeks after the end of treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: all patients with positive Helicobacter pylori test after endoscopy. Exclusion criteria: dissatisfaction with continued cooperation, drug sensitivity and severe side effects of contraindications to levofloxacin
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Intervention groups
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the intervention group will use a four-drug regimen containing levofloxacin 500 daily, pantoprazole 20 twice daily, bismuth tablets every 12 hours, and amoxicillin 1 g every 12 hours.
the control group of the usual four-drug treatment group underwent clarithromycin 500 twice daily, pantoprazole 20 twice daily, bismuth tablets every 12 hours and amoxicillin 1 g every 12 hours.
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Main outcome variables
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Eradication of Helicobacter pylori