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.

Comparison of the effectiveness of three treatment regimens, including the two-drug regimen of amoxicillin-venoprazan, the three-drug regimen of amoxicillin-venoprazan-levofloxacin, and the four-drug regimen of omeprazole, amoxicillin, metronidazole, and bismuth, in eradicating Helicobacter pylori.

Clinical trial, with 3 parallel groups, randomized, single-blind, phase 3 on 150 patients. Randomization via the rand function of Excel software

This clinical trial is being conducted at the Gastroenterology Clinic of Taleghani Hospital. Patients with Helicobacter pylori infection will be randomly assigned to three different treatment groups in a 1:1:1 ratio. The primary outcome measure, the stool antigen test result, will be assessed 6 to 8 weeks after the end of treatment. This study is a single-blind design, with only the outcome assessor blinded to the type of intervention participants received.

Inclusion criteria: Definite diagnosis of Helicobacter pylori infection, willingness to participate in the study, and completion of the treatment course. Exclusion criteria: History of previous treatment for Helicobacter pylori eradication, use of antibiotics or proton pump inhibitors within the past 4 weeks.

The first group received a two-drug regimen of amoxicillin 1 g twice daily and venoprazan 20 mg twice daily for 10 days. The second group received a three-drug regimen of amoxicillin 1 g twice daily, venoprazan 20 mg twice daily, and levofloxacin 500 mg once daily. The third group received the four-drug regimen of esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, metronidazole 500 mg twice daily, and bismuth 240 mg twice daily. The duration of drug administration was 14 days.

Helicobacter pylori eradication, treatment safety

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.

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.

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.

After publishing the paper

Researchers in the fields of Internal medicine and gastroenterology

For research purposes and with attribution.

connection with the corresponding authors Dr. Shabnam Shahrokh shabnamsharokh@gmail.com

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