Comparing the effectiveness of the four-drug regimen containing levofloxacin with the effectiveness of the four-drug regimen containing metronidazole in the treatment of Helicobacter pylori eradication

Comparing the efficacy of levofloxacin and metronidazole regimens in the quadruple treatment of Helicobacter pylori eradication

A clinical trial with a control group with parallel groups, randomized with blocks, one-sided blind, randomized phase 3 on 162 patients.

In this single-blind clinical trial, patients referred to the Gastroenterology Clinic of Taleghani Hospital, Tehran, suffering from Helicobacter pylori are admitted. Division of groups will be 1:1 with parallel arms and using random blocks (block size four). The first group will receive the quadruple treatment of omeprazole, bismuth, amoxicillin and levofloxacin and the second group will receive the quadruple treatment of omeprazole, bismuth, amoxicillin and metronidazole. The duration of treatment is 14 days. Before and after the intervention, patients are evaluated for Helicobacter pylori infection with stool antigen test. Patients will be referred to evaluate the root of Helicobacter pylori two weeks after the end of the treatment.

Inclusion criteria: Helicobacter pylori-positive patients. Exclusion criteria: previous allergic reaction to antibiotics (amoxicillin, clarithromycin, tinidazole), patients taking probiotics and proton pump inhibitors (esomeprazole), occurrence of side effects due to simultaneous use of four drugs and the need to stop taking one of medications, pregnancy

The first group will receive the quadruple treatment of omeprazole, bismuth, amoxicillin and levofloxacin and the second group will receive the quadruple treatment of omeprazole, bismuth, amoxicillin and metronidazole.

Eradication of Helicobacter pylori, occurrence of drug side effects

Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block, two, four or six patients will be included in the study order. Random allocation of blocks of patients to two intervention groups will be done through Sealed Envelope online software. By referring to https://www.sealedenvelope.com/simple-randomiser/v1/lists by specifying the total number of samples, the number of possible samples in each randomized block (2, 4 and 6 patients) randomization by online software is done For example, like the following output: block identifier block size sequence within block treatment 1 2 1 Group B 1 2 2 Group A 2 4 1 Group A 2 4 2 Group B 2 4 3 Group B 2 4 4 Group A 3 2 1 Group A 3 2 2 Group B ... which is the block number, the number of patients in the block, and the random assignment of each patient (with the corresponding number) to the treatment group. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis.

Protecting patients' privacy and confidentiality

Only the information related to the study protocol, the statistical analysis plan and the clinical study report will be made available to the requestors (and not publicly) to other researchers for guidance for further studies.

After the publication of the article

Researchers, students and professors in the field of gastroenterology

For use in further research and if the source is cited

corresponding author Dr Amir Sdaeghi amirsadeghimd@yahoo.com

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