Comparison of the Efficacy and Safety of Vonoprazan-Based Triple Therapy versus Esomeprazole-Based Triple Therapy for Helicobacter pylori Eradication

Comparison of the Efficacy and Safety of Vonoprazan-Based Triple Therapy versus Esomeprazole-Based Triple Therapy for Helicobacter pylori Eradication

This study is a randomized clinical trial conducted in the internal medicine ward of Imam Khomeini Hospital in Ahvaz on patients infected with Helicobacter pylori. Patients aged 18 to 65 years with a positive H. pylori test and no prior treatment history will be enrolled. Exclusion criteria include recent use of antibiotics or acid-suppressing drugs, active complicated peptic ulcer, history of gastric surgery, drug allergies, severe physical or psychiatric illnesses, pregnancy or lactation, and history of alcohol or substance abuse. Patients will be randomly assigned to two treatment groups using permuted block randomization (block sizes of 4, 6, and 8). Allocation will be concealed using opaque, sealed, and sequentially numbered envelopes to ensure that the assigned group is unknown before enrollment (concealment allocation). Participants will be blinded to the type of treatment they receive. After group assignment, patients will receive the corresponding therapy for H. pylori eradication.

The present study is a randomized clinical trial conducted in the internal medicine ward of Imam Khomeini Hospital in Ahvaz on patients infected with Helicobacter pylori.

Their test results indicate a positive Helicobacter pylori infection.

Triple Therapy Group A: Vonoprazan 20 mg twice daily, Amoxicillin 1 g twice daily, Clarithromycin 500 mg twice daily for 14 days. Triple Therapy Group B: Esomeprazole 20 mg twice daily, Amoxicillin 1 g twice daily, Clarithromycin 500 mg twice daily for 14 days.

Helicobacter pylori eradication rate: Safety and adverse effects of treatment:

In this study, interventions are assigned to participants according to a pre-generated randomization list. For allocation concealment, we use the concealment allocation method, which ensures that the assigned group of a participant is not known before the assignment. Opaque, sealed, and sequentially numbered envelopes are used, where each randomization sequence is recorded on a card and placed inside the envelopes in order. To maintain the randomization sequence, the external surface of the envelopes is numbered correspondingly. The envelopes are then sealed and placed sequentially in a box. At the time of participant enrollment, based on the order of eligible participants, an envelope is opened, revealing the treatment group assigned to that participant. After patients are allocated to the two treatment groups following the diagnosis of Helicobacter pylori infection and confirmation of eligibility, participants remain blinded to the type of treatment they receive.

This study uses a single-blind design, in which participants are unaware of their assigned treatment group. Allocation to treatment groups is concealed using opaque, sealed, and sequentially numbered envelopes, each containing a pre-generated randomization assignment. Envelopes are opened sequentially upon participant enrollment, revealing the allocated intervention. In addition to participants, clinical caregivers, outcome assessors, and data analysts are blinded to each participant’s treatment allocation to minimize bias.

In this study, individual participant data (IPD) will be available after completion of the research and following proper de-identification to ensure confidentiality. Data related to the primary outcome (eradication of Helicobacter pylori) and secondary outcomes (adverse drug reactions and other related outcomes) will be shared in the form of anonymized datasets. Other study documents, including the study protocol, questionnaires, and case report forms (CRFs), will also be available upon reasonable request by qualified researchers. Data sharing will only take place after submission of a formal written request and subsequent approval by the Ethics Committee and the research team.

The study data and documents will be available to eligible researchers starting 6 months after the publication of the final results in peer-reviewed journals, for a period of 3 years. After this period, access will only be granted upon approval by the ethics committee and the research team.

Individuals who are allowed to access the data/documents include academic researchers, postgraduate students, and other qualified investigators who submit a formal request and obtain approval from the ethics committee and the research team.

The data/documents will be available exclusively for research and scientific purposes, and their use will be permitted only upon formal request, approval from the ethics committee, and strict adherence to participant confidentiality.

To obtain the data/documents, interested researchers may contact the principal investigator at the Department of Internal Medicine, Imam Khomeini Hospital, or Ahvaz Jundishapur University of Medical Sciences.

Requests for access to the data/documents must be submitted in writing to the principal investigator. Upon receipt, the research team and ethics committee will review the request. If approved, the data will be provided to the requesting researcher after removal of any identifying information and in accordance with confidentiality regulations.