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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-Line Therapy with Omeprazole | Experimental |
| |
| First-Line Therapy with Vonoprazan | Experimental |
| |
| Second-Line Therapy with Omeprazole | Experimental |
| |
| Second-Line Therapy with Vonoprazan | Experimental | Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin 500 mg | Drug | Clarithromycin 500 mg orally twice daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori Eradication Rate | Proportion of participants with successful eradication of Helicobacter pylori infection, confirmed by a negative stool antigen test. | 4-6 weeks after completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Number and type of treatment-related adverse effects (e.g., nausea, diarrhea, headache, abdominal discomfort) reported by participants during or after therapy | During the 6-week treatment and follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taimur khan, FCPS | Contact | 03305485960 | 3638 | taimur.khan@rmi.edu.pk |
| Naseer Ahmed, Associate professor | Contact | 09291583000 | 4743 | dr.naseerahmed99@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehman Medical Institue | Peshawar | K | 092 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39131848 | Background | 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. | |
| 38036941 |
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| Amoxicillin 1 g | Drug | Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks |
|
| Omeprazole 40 mg | Drug | Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks |
|
| Clarithromycin 500 mg | Drug | Clarithromycin 500 mg orally twice daily for 14 days |
|
| Amoxicillin 1 g | Drug | Amoxicillin 1 g orally twice daily for 14 days |
|
| Vonoprazan 20 mg | Drug | Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks |
|
| Levofloxacin 500 mg | Drug | Levofloxacin 500 mg orally once daily for 14 days |
|
| Amoxicillin 1 g | Drug | Amoxicillin 1 g orally twice daily for 14 days |
|
| Omeprazole 40 mg | Drug | Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks |
|
| Levofloxacin 500 mg | Drug | Levofloxacin 500 mg orally once daily for 14 days |
|
| Amoxicillin 1 g | Drug | Amoxicillin 1 g orally twice daily for 14 days |
|
| Vonoprazan 20 mg | Drug | Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks |
|
| 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. |
| 35810638 | Background | 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. |
| 32327613 | Background | Kim GH. Proton Pump Inhibitor-Related Gastric Mucosal Changes. Gut Liver. 2021 Sep 15;15(5):646-652. doi: 10.5009/gnl20036. |
| 31243237 | Background | 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. |
| 31536675 | Background | 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. |
| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| D009853 | Omeprazole |
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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