Comparison of the efficacy of Vonoprazan with omeprazole in the quadruple therapy of Helicobacter pylori infection

Comparison of the efficacy of vonoprazan versus omeprazole in Helicobacter pylori quadruple therapy

This double-blind clinical trial utilizes block randomization to allocate 150 participants equally into an intervention group (Group A, n:75) and a control group(Group B, n:75).

A double-blind, case-control clinical trial conducts at two hospitals in Isfahan. 150 consecutive patients aged 18 to 50, presenting with symptoms of dyspepsia and testing positive for *Helicobacter pylori* via endoscopic biopsy, are enrolled in the study.

Inclusion is defined as being between the ages of 18 and 50 and having a diagnosis confirmed by a positive endoscopic biopsy. Exclusion criteria for the study are as follows: 1) Antibiotic treatment within the past 3 months, 2) Use of H2 receptor antagonists, bismuth, or PPIs within 2 weeks prior to the study start, 3) A history of Helicobacter pylori eradication therapy within the past 5 years, 4) Use of NSAIDs and corticosteroids, 5) Severe comorbidities such as malignant disease, or a history of upper gastrointestinal issues such as diaphragmatic hernia, Barrett's esophagus, and achalasia, 6) Pregnancy or lactation, 7) A history of using immunosuppressive drugs, 8) Patients with inherited immunodeficiency, 9) Patients with poorly controlled diabetes, 10) Individuals unable to adhere to the treatment protocol.

The intervention group received a 14-day ciprofloxacin-based quadruple therapy regimen: Ciprofloxacin (500 mg b.i.d.), Amoxicillin (500 mg b.i.d.), Vonoprazan (10 mg b.i.d.), and Bismuth (120 mg q.i.d.).

Improvement of disease symptoms- Improvement of side effects from the quadruple therapy drugs- Negative H. pylori stool antigen test

The randomization technique employed in this study is the block method. In this process, patients are first divided into groups of four. Next, blocks representing four different arrangements of groups A and B are defined—specifically AABB, ABAB, ABBA, BBAA, BABA, and BAAB—resulting in a total of six block types. Subsequently, Microsoft Excel is used to generate random numbers corresponding to the number of groups; the groups are then sorted based on these numbers (in ascending order) and assigned to the designated blocks. Finally, the patients previously assigned to each group are allocated to one of the intervention groups (A or B) according to the sequence established within their respective blocks. Finally, using the numbered-envelope technique, groups A and B are assigned to either the intervention or the control group. In this way, patients are randomly distributed in equal numbers between the two study groups; Group A is designated as the intervention group, and Group B as the control group.

In this study, a double-blind design will be used. Both the participants and the principal investigators will be completely blinded to the assignment of the study groups (study treatment or routine treatment). This will be achieved by preparing the study drug and the routine drug coded with a unique serial number, without disclosure of the drug type. The manuscript authors will remain blinded to the identity of the groups until the completion of recruitment, database lock, and the initial analysis

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Islamic Azad university- Najafabad Branch

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