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IRCT20200422047167N2 IRCT 2026-07-08 Shiraz University of Medical Sciences Randomized controlled trial of three Vonoprazan based treatment regimens for eradication of Helicobacter pylori infection RCTVREHP Randomized controlled trial of three Vonoprazan based treatment regimens for eradication of Helicobacter pylori infection: a triple-blind clinical trial study. 2026-06-22 anticipated 330 Recruiting https://irct.ir/trial/90230 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In addition to the primary ITT-based analysis, a secondary Per-Protocol (PP) analysis will be conducted, in which only patients who fully complied with the treatment protocol and completed the study follow-up will be included in the analysis. This analysis is performed to assess the effectiveness of the intervention in the context of full adherence to treatment, Randomization description: lock randomization will be used in a 1:1:1 ratio to randomly and equally allocate participants to three treatment groups. Randomization will be performed by an independent individual from the treatment team to prevent any bias in patient allocation. After applying concealed allocation, patients will be divided into three groups in the following manner: 110 envelopes numbered 1 to 110 A, 110 envelopes numbered 1 to 110 B, and 110 envelopes numbered 1 to 110 C. A trained expert will randomly assign one of the envelopes to the patients, and after obtaining informed consent, they will enter the study, Blinding description: After applying concealed allocation, the patients were divided into three groups in the following manner: 20 packets numbered 1 to 20 A and 20 packets numbered 1 to 20 B were prepared, and a secretary randomly gave one of the packets to the patients, and the people in group A entered the antibiotic treatment regimen, and the people in group B entered the combination treatment regimen of mint tablets and green tea. After providing the necessary explanations and obtaining informed consent, they entered the study. In this study, people who refer to a specialist at Motahari Clinic in Shiraz with symptoms of heartburn and reflux and have a positive H. pylori sampling or breath test will be included in the study. After obtaining written informed consent from the participants, the randomization process will be performed using a random block method with a ratio of 1:1 so that the participants will be randomly placed in one of the two treatment groups. The first group will receive standard H. pylori treatment including antibiotics and omeprazole for one month. The second group will take two herbal medicines, peppermint (Supermint) and green tea (Camellia sinensis), for one month in addition to the standard treatment. The first group will be given a placebo pill of the same shape and size instead of the herbal medicine. The study is designed as a double-blind study, meaning that neither the patients nor the treating physicians will know which treatment they are receiving. Randomization and coding of the drugs will be performed by an independent person from the treatment team. The drug packages will be provided to the patients in the same way and without a name indicating the type of treatment. The outcome assessment will be performed by an independent team of clinical researchers to avoid any bias. After the treatment period (one month), stool samples will be taken from all patients. Fecal antigens will be measured using a special kit using the ELISA method. 3 Helicobacter Pylori infection. Intervention 1: The first Intervention group will receive a drug regimen consisting of 20 mg of vonoprazan four times a day and 1000 mg of amoxicillin four times a day for 7 days. The continuation of this arm will be subject to the results of the interim analysis and subsequent decision-making. Intervention 2: The second Intervention group will receive 20 mg of vonoprazan twice a day and 240 mg of bismuth subcitrate twice a day and 500 mg of amoxicillin four times a day and 500 mg of metronidazole three times a day for 10 days. Intervention 3: The third Intervention group of drug regimens includes omeprazole 20 mg twice a day and bismuth subcitrate 240 mg twice a day and amoxicillin 500 mg four times a day and metronidazole 500 mg three times a day for 14 days. Yes - There is a plan to make this available What will be shared: Data on the main outcome of participants can be shared after de-identification. When: Access starts from March 30, 2027 To whom: Data will only be available to principal investigators and researchers working in academic and scientific institutions. Conditions: If requested by the supervisor of the project and the reviewers of the article, the authorized data will be provided to the people. Where to obtain: Seyedeh Azra Shamsdin How to obtain: The applicant can request research data by email. Comments: If the data and their analysis are requested by the supervisor or university referees, they will be provided to them by email.
public Seyedeh Azra Shamsdin
Gasteroenterohepatology Research Center , Mohammad Rasoolallah Research Tower, Khalili Street, Shiraz
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3628 1442 shamsdina@sums.ac.ir Shiraz University of Medical Sciences scientific Kamran Bagheri Lankarani
Health Policy Research Center,8th Floor,Shiraz Faculty of Medical Sciences, Zand Street,Shiraz
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3208 4440 kblankarani@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 1- Patients with H. pylori who have a positive written result of urea breath test or stool antigen test or pathological test. 2- Patients who have not received any anti-H. pylori treatment in the past three months. 3- Individuals over 18 years of age. 18 years no limit Both 1 - Individuals without a confirmed test and a positive written result for H. pylori. 2- Individuals who have been treated for cancer. 3- Patients who have taken antibiotics for any reason in the past four weeks. 4- Patients who have taken immunosuppressive drugs. 5- Individuals with underlying cardiovascular diseases, advanced liver diseases, or renal failure. 6- Pregnant or lactating women. K93 Disorders of other digestive organs in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Treatment - Drugs The first Intervention group will receive a drug regimen consisting of 20 mg of vonoprazan four times a day and 1000 mg of amoxicillin four times a day for 7 days. The continuation of this arm will be subject to the results of the interim analysis and subsequent decision-making. The second Intervention group will receive 20 mg of vonoprazan twice a day and 240 mg of bismuth subcitrate twice a day and 500 mg of amoxicillin four times a day and 500 mg of metronidazole three times a day for 10 days. The third Intervention group of drug regimens includes omeprazole 20 mg twice a day and bismuth subcitrate 240 mg twice a day and amoxicillin 500 mg four times a day and metronidazole 500 mg three times a day for 14 days. Percentage of people in each of the target groups whose stool antigen test results changed after treatment. Timepoint: Before starting treatment and after completing the treatment period (6 weeks), stool samples will be taken from all patients to examine Stool Antigen. Method of measurement: Determination of Helicobacter pylori antigen in feces is measured with a special kit using the ELISA method. Shiraz University of Medical Sciences Approved 2026-04-27 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences,Zand Avenue, Shiraz ,Iran Shiraz Fars Iran (Islamic Republic of)