Comparison of the effectiveness of administering amoxicillin 3 or 4 times daily in triple-drug regimens containing esomeprazole, bismuth, and amoxicillin for eradication of Helicobacter pylori in patients with this infection

Comparison of 3 or 4 times daily amoxicillin administration in the eradication of H. pylori in a 14-day regimen of bismuth triple therapy

The clinical trial with two parallel groups, single blind, randomized, phase 3 is conducted on 200 patients. For randomization, rand function of Excel software was used and 100 patients were placed in each group.

In this study, 200 people with dyspepsia who refer to the gastroenterology clinic of Imam Sari Hospital, who have an indication for endoscopy and the presence of Helicobacter pylori is proven in the biopsy, and who have not previously received a Helicobacter pylori eradication regimen, are assigned to groups A or B based on a random table. The treating physician is aware of the type of treatment, but the others in the research group are unaware.

Patients over 18 years of age who undergo endoscopy and are confirmed to have Helicobacter pylori and have not been treated for this microbe will be included in the study. Patients with underlying medical conditions, previous anti-H. pylori treatment, history of gastric surgery, and history of gastrointestinal malignancy will be excluded from the study.

In both groups, patients will receive bismuth 240 mg three times daily and esomeprazole 40 mg twice daily for 14 days. However, the dose of amoxicillin in group A will be 1 g three times daily and in group B 750 mg four times daily.

the eradication rate of Helicobacter pylori

Random allocation will be done by block method (Randomization Block) with a block size of four and using Sealed Envelope online software at the address https://www.sealedenvelope.com at an individual level and by an Biostatistician researcher who is a member of the research team. In this site, which is an online software for creating random allocation, the create list option is selected through the randomization menu, and then the required parameters such as groups A and B, the number of blocks, which is 4, and the total number of samples will be entered. And finally the random allocation list will be created. A sealed non-transparent envelope will be used for concealment. Researchers enroll eligible participants after the baseline assessment, then remove and open each envelope in the order that corresponds to the participant's initial assessment order, and assign the eligible participant to either the intervention group or the control group.

In this study, the care provider, investigator, outcome assessor, and safety committee are the physicians who are implementing the plan and are not blinded to the prescribed medication regimen. The participant and data analyst are blinded.

After de-identifying the participants in the study, the information related to the results of the interventions as well as the possible side effects of the intervention will be published according to the method of the intervention.

The access period starts 1 month after the results are published

The data will be available only to researchers working in academic and scientific institutions

The data can be obtained only to compare and check the effect of different treatment regimens. The data related to the acceptance rate of different treatment regimens and the amount of side effects in each treatment regimen can be received.

masoud.hosseini@mazums.ac.ir

After reviewing the request, the data will be sent within a maximum period of one week