Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clarithromycin 500 mg, Amoxicillin 1 g, Omeprazole 40 mg, Clarithromycin 500 mg.
- Who it may be relevant to
- Registry conditions: H Pylori. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Efficacy of Omeprazole and Vonoprazan in the Treatment of Helicobacter Pylori Infection
Overview
Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations. This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.
Detailed description
Currently, there are numerous H. pylori eradication regimens, but opinions vary regarding the effectiveness of those based on P-CAB or PPI. Zhang et al. 4 concluded that the P-CAB-based triple regimen was superior to the PPI-based regimen, whereas Du et al.5 suggested that a vonoprazan and amoxicillin duo regimen may be the preferred first-line option for H. pylori eradication in clinical practice. However, due to limited evidence, the efficacy of various H. pylori eradication regimens using tegoprazan or vonoprazan could not be compared.
Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations.
This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.
Objective: To compare the efficacy of vonoprazan-based H. pylori eradication therapy with conventional proton pump inhibitors based therapy.
Interventions
- Drug Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days - Drug Amoxicillin 1 g
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks - Drug Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks - Drug Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days - Drug Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days - Drug Vonoprazan 20 mg
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks - Drug Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days - Drug Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days - Drug Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks - Drug Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days
Primary outcome measures
- H. pylori Eradication Rate [Time frame: 4-6 weeks after completion of therapy]
Secondary outcome measures (1)
- Incidence of Adverse Events [Time frame: During the 6-week treatment and follow-up period]
Eligibility criteria
Inclusion criteria
- All patients who tested positive on stool antigen
Exclusion criteria
- patients under 12 years old.
- Patients who have penicillin allergy.
- Patients who have underlying dysrhythmia forbidding the use of macrolide -. Patient who have hypersensitivity to any of these antibiotics or proton pump inhibitors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Rehman Medical Institue — Peshawar
Publications
- Malfertheiner P, Moss SF, Daniele P, Pelletier C, Jacob R, Tremblay G, Hubscher E, Leifke E, Chey WD. Potassium-Competitive Acid Blocker and Proton Pump Inhibitor-Based Regimens for First-Line Helicobacter pylori Eradication: A Network Meta-Analysis. Gastro Hep Adv. 2022 Jun 17;1(5):824-834. doi: 10.1016/j.gastha.2022.06.009. eCollection 2022. PMID 39131848
- Du RC, Hu YX, Ouyang Y, Ling LX, Xu JY, Sa R, Liu XS, Hong JB, Zhu Y, Lu NH, Hu Y. Vonoprazan and amoxicillin dual therapy as the first-line treatment of Helicobacter pylori infection: A systematic review and meta-analysis. Helicobacter. 2024 Jan-Feb;29(1):e13039. doi: 10.1111/hel.13039. Epub 2023 Nov 30. PMID 38036941
- Zhang M, Pang M, Zhang M. Efficacy and safety of potassium-competitive acid blockers versus proton pump inhibitors as Helicobacter pylori eradication therapy: a meta-analysis of randomized clinical trials. Clinics (Sao Paulo). 2022 Jul 7;77:100058. doi: 10.1016/j.clinsp.2022.100058. eCollection 2022. PMID 35810638
- Kim GH. Proton Pump Inhibitor-Related Gastric Mucosal Changes. Gut Liver. 2021 Sep 15;15(5):646-652. doi: 10.5009/gnl20036. PMID 32327613
- Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27. PMID 31243237
- Sun Y, Zhang J. Helicobacter pylori recrudescence and its influencing factors. J Cell Mol Med. 2019 Dec;23(12):7919-7925. doi: 10.1111/jcmm.14682. Epub 2019 Sep 19. PMID 31536675
Identifiers
NCT: NCT07040839 · RMI/RMI-REC/approval 182