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Study aim
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Comparison of the efficacy of 12-day concomitant and 14-day high-dose triple therapy on Helicobacter pylori eradication
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Design
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Phase 3 randomized clinical trial with control group, on 240 patients with Helicobacter pylori infection
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Settings and conduct
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In this randomized clinical trial, 240 patients with symptoms of indigestion referred to Tooba Gastroenterology Clinic and Imam Hospital in Sari city, Mazandaran province, after upper gastrointestinal endoscopy, will be included in the study, according to the inclusion and exclusion criteria.
Randomization was performed according to the randomization table extracted from the internet.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria was ages between 18 and 80 years who have H. pylori infection and have endoscopic findings of gastric ulcer or erosion, duodenal ulcer or duodenitis and or histologic evidence of intestinal metaplasia. Exclusion criteria: Pregnant or nursing women, those with a history of upper GI surgery, major cardiac, lung, liver or renal diseases, a history of previous H. pylori eradication regimen and history of known side effects to the protocol drugs would be excluded from the study.
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Intervention groups
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1- Control group that received the standard 4-drug regimen of PPI, amoxicillin, metronidazole, and clarithromycin.
2- Case group that received the high-dose 3-drug regimen of PPI, amoxicillin, and bismuth.
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Main outcome variables
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Success rate of this regimen in eradicating Helicobacter pylori, patient tolerance, drug side effects