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For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bismuth-amoxicillin-vonoprazan triple therapy | Active Comparator | vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day |
|
| vonoprazan-amoxicillin dual therapy | Active Comparator | vonoprazan 20mg twice a day + amoxicillin 750mg,Four times a day |
|
| proton pump inhibitor-based standard triple therapy | Active Comparator | rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vonoprazan, amoxicillin, tripotassium dicitrate bismuthate | Drug | bismuth-amoxicillin-vonoprazan triple therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| the eradication rate of Helicobacter pylori | evalute eradication outcome by 13C urea breath test | 8 week after finishing study drugs |
| Measure | Description | Time Frame |
|---|---|---|
| genotype analysis | CYP3A4, CYP2C19 and IL-1B -511 genotypes | 1 day |
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Inclusion Criteria:
(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deng-Chyang Wu, MD, PHD | Contact | 88673121101 | 7451 | dechwu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
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| vonoprazan, amoxicillin | Drug | vonoprazan-amoxicillin dual therapy |
|
| rabeprazole, amoxicillin, clarithromycin | Drug | proton pump inhibitor-based standard triple therapy |
|
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| D064750 | Rabeprazole |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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