Evaluation and comparison of the efficacy of triple therapies regimens containing bismuth with high dose and different doses of amoxicillin for eradicating Helicobacter pylori infection

Determination of H. pylori eradication with a 14-day regimen containing high doses of amoxicillin Determination of H. pylori eradication with a 14-day regimen containing moderate dose of amoxicillin Determining and comparing the acceptance of treatment by patients during treatment Determining and comparing the demographic characteristics of patients and evaluating their effect on H. pylori eradication Determining and comparing endoscopic findings in patients Determining the relationship between each endoscopic/demographic characteristic with H. pylori eradication Determining and comparing the severity of drug side effects in the two groups Determining and comparing drug discontinuation

Demographic information of patients will be recorded in the questionnaire. At the end of treatment, patients are visited and asked about the side effects of treatment, the severity of side effects (uncomplicated, mild, moderate, and severe), and the compliance rate of treatment (good, moderate, and poor). Eight weeks after the end of treatment, the eradication rate of H. pylori is evaluated using the Fecal H. pylori Antigen method.

Imam Khomeini Hospital, Sari

Individuals over 18 years with dyspepsia who were indicated for the eradication of H. pylori and had not previously received eradication treatment are randomly assigned to the study. Patients with a history of chronic diseases, malignancies, and gastric surgery are excluded.

The first group (high dose group): amoxicillin 1 gr TDS, bismuth 240 mg TDS, and esomeprazole 40 mg bid for 14 days The second group (moderate dose group): amoxicillin 750 mg TDS, bismuth 240 mg TDS, and esomeprazole 40 mg BID for 14 days

Stool Ag test result Drug acceptance and Side effects rate

Patients are randomly randomized into blocks of 10 patients by a computer program and entered into the corresponding group of pre-prepared sets of numbers, respectively.

Depending on the diagnosis, patients will undergo eradication study and treatment, but will not be informed of the type of treatment (receiving the first group or the second group). The information of the patients of the two groups, with a non-specific name that is a definition of the study groups (for example, groups A and B) and only the main researcher knows the definition (B: high dose group and A: medium-dose group), will be available to the analyzer. Therefore, the analyzer is not aware of the type of drugs received in each group.

All data can be shared when participants are not identifiable

Ability to access data 6 months after publishing the results

The data will be available to academic researchers and non-academic physicians

Perform other analyzes and extract more results

Please refer to the e-mail address of the responsible author

Submit a request to the Deputy of research and technology of the University / Refer the request to the relevant author of the project