Comparing the efficacy of the bismuth-based quadruple therapy containing a high dose of metronidazole with a concomitant regimen containing clarithromycin for eradicating Helicobacter pylori infection

Determining and comparing H. pylori eradication with bismuth quadruple therapy containing high doses of metronidazole with concomitant quadruple regimen

A clinical trial with two intervention groups, with parallel groups, double-blind, randomized, phase 2-3 on 200 patients. A computer program was used for randomization.

Patients with the indication of H. pylori eradication in Imam Khomeini Hospital Sari are randomly assigned to two drug groups A and B. 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.

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 A group (high dose metronidazole): amoxicillin 1 gram twice a day, metronidazole 1 gram twice a day, bismuth 240 milligrams twice a day, and pantoprazole 40 milligrams twice a day for 14 days. The B group (concomitant): amoxicillin 1 gram twice a day, metronidazole 500 milligrams twice a day, clarithromycin 500 milligrams twice a day, and pantoprazole 40 milligrams twice a day for 14 days

H. pylori eradication

Patients are randomly randomized into blocks of 6 and 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 (Bismuth-containing quadruple and B: Concomitant quadruple), 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 Deputy of Research and Technology of the University of Mazandaran University of Medical Sciences (via automation application or e-mail address, ebrahimnejad@mazums.ac.ir).

The applicant submits a request for documents or data files related to this trial (which contain the applicant's e-mail address or mailing address) to the Deputy of Research and Technology of the University of Mazandaran University of Medical Sciences (via automation application or e-mail address, ebrahimnejad@mazums.ac.ir). If approved, this request will be referred to the responsible author of the project, Dr. Arash Kazemi. Then the data will be sent to the declared address.