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IRCT20220417054557N3 IRCT 2025-11-26 Shahid Beheshti University of Medical Sciences Comparing the effectiveness of three different treatment regimens in eradicating Helicobacter pylori Comparison of the effectiveness of three treatment regimens including a two-drug regimen of amoxicillin and venoprazone, a three-drug regimen of amoxicillin, venoprazone, and levofloxacin, and a four-drug regimen of esomeprazole, amoxicillin, metronidazole, and bismuth in eradicating Helicobacter pylori. 2025-11-22 anticipated 150 Complete https://irct.ir/trial/87647 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization process will be performed as a random block with an individual randomization unit. The randomization sequence will be generated using statistical software and computer-generated random numbers to minimize the possibility of bias. The block sizes will be chosen as variables to reduce the predictability of allocations. After generating the randomization sequence, individuals will be assigned to three treatment groups in a 1:1:1 ratio. The randomization pattern will be performed without the use of stratification, and all participants will enter one of the three treatment arms based on a predetermined sequence. To ensure allocation concealment, the randomization sequence will be placed in opaque, numbered, and sealed envelopes, and the person responsible for enrolling participants will not have access to the contents of the envelopes; thus, the treatment group assignment for each participant will not be predictable before the envelope is opened. This method prevents premature sequence disclosure and bias, making the randomization process completely safe and reliable, Blinding description: In this study, blinding is performed in a single-blind manner, with only the outcome assessor being blinded to the type of intervention received by the participants. Participants, prescribing physicians, the principal investigator, and the treatment team are aware of the type of treatment regimen each participant is receiving, and blinding is not possible or necessary for these groups. To ensure blinding of the outcome assessor, stool antigen test samples collected 6 to 8 weeks after the end of treatment are sent to the laboratory unit with anonymous codes and without mentioning the type of treatment regimen. The outcome assessor only records the test results and has no access to information related to group allocation. This method prevents any bias in recording the primary outcome of the study and maintains the single-blind nature of the study. 3 Helicobacter pylori infection. Intervention 1: Intervention group: Two-drug regimen including amoxicillin 1 gram twice daily and venoprazan 20 mg twice daily for 14 days. All drugs are products of Abidi Company. Intervention 2: Intervention group: Triple-drug regimen including amoxicillin 1 g twice daily, venoprazan 20 mg twice daily, and levofloxacin 500 mg once daily for 14 days.All drugs are products of Abidi Company. Intervention 3: Intervention group: OMAB regimen includes esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, metronidazole 500 mg twice daily, and bismuth 240 mg twice daily for 14 days.All drugs are products of Abidi Company. Yes - There is a plan to make this available What will be shared: The data file related to the primary outcome, Helicobacter pylori eradication, will be shared in coded form. The study protocol, SPSS statistical analysis file, clinical study report, and other data will also be provided to other researchers upon request. When: After publishing the paper To whom: Researchers in the fields of Internal medicine and gastroenterology Conditions: For research purposes and with attribution. Where to obtain: connection with the corresponding authors Dr. Shabnam Shahrokh shabnamsharokh@gmail.com How to obtain: Send an email to the responsible author and state the reason for the request. Comments:
public Mahbod Sianpanah
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2526 mahbod.sianpanah@gmail.com Shahid Beheshti University of Medical Sciences scientific shabnam Shahrokh
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2526 shabnamshahrokh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 to 70 years Definite diagnosis of Helicobacter pylori infection Willingness and ability to participate in the study and complete the treatment course 18 years 70 years Both History of previous treatment for Helicobacter pylori eradication Taking antibiotics or proton pump inhibitors within the past four weeks Known allergy to any of the drugs used in the study Having significant underlying diseases or comorbidities B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Two-drug regimen including amoxicillin 1 gram twice daily and venoprazan 20 mg twice daily for 14 days. All drugs are products of Abidi Company. Intervention group: Triple-drug regimen including amoxicillin 1 g twice daily, venoprazan 20 mg twice daily, and levofloxacin 500 mg once daily for 14 days.All drugs are products of Abidi Company. Intervention group: OMAB regimen includes esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, metronidazole 500 mg twice daily, and bismuth 240 mg twice daily for 14 days.All drugs are products of Abidi Company. Helicobacter pylori eradication. Timepoint: 8 weeks after the start of the intervention. Method of measurement: Stool antigen test. Side effects. Timepoint: During the 14-day treatment period. Method of measurement: Clinical history. Shahid Beheshti University of Medical Sciences Approved 2025-09-22 Research Ethics Committee, Institute of Gastroenterology and Liver Diseases, Shahid Beheshti Univers Arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)