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Helicobacter pylori (H.pylori) infect more than 50% of humans globally. This study were (1) to test whether the efficacies of 14-day PCAB-based high-dose dual therapy and 14-day PPI-based reverse hybrid therapy can achieve a higher eradication rate than 14-day PCAB-based triple therapy in the first-line treatment of H pylori infection, (2) to compare the eradication rates of 14-day PCAB-based and PPI-based bismuth quadruple therapies in the second-line treatment of H pylori infection, and (3) to examine the impacts of antibiotic resistance of H pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14-day vonoprazan high-dose two-in-one therapy | Active Comparator | vonoprazan 20mg bid and amoxicillin 750mg qid |
|
| 14-day vonoprazan triple therapy | Active Comparator | vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid |
|
| 14th Rabeprazole reverse mixed therapy | Active Comparator | first 7 days rabeprazole 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid and metronidazole 500mg bid Next 7 days rabeprazole 20mg bid and amoxicillin 1gm bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan and Amoxicillin | Drug | 14-day vonoprazan high-dose two-in-one therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| the rate of Helicobacter pylori | Evaluate eradication outcome by 13C uear breath test | 6 week after finishing study drugs |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions | drugs | 2weeks after finishing study drugs |
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Inclusion Criteria:
Subjects infected with Helicobacter pylori.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deng-Chyang Wu, MD, PhD | Contact | 886-7-*3121101 | 7451 | dechwu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40560185 | Derived | Hsu PI, Chen CL, Shih CA, Chen KY, Tai WC, Chuah SK, Lee CL, Tsay FW, Yang JC, Lei WY, Kuo CH, Shie CB, Lee HC, Yamaoka Y, Graham DY, Wu DC; Taiwan Acid-related Disease and Microbiota (TARD-M) Consortium. Vonoprazan High-Dose Dual, Vonoprazan Triple, and Rabeprazole Reverse Hybrid Therapies for First-Line Treatment of Helicobacter pylori Infection: A Multicenter Randomized Trial. Am J Gastroenterol. 2025 Jun 16. doi: 10.14309/ajg.0000000000003607. Online ahead of print. |
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| Vonoprazan, Amoxicillin and Clarithromycin | Drug | 14-day vonoprazan triple therapy |
|
| Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole | Drug | 14th Rabeprazole reverse mixed therapy |
|
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D064750 | Rabeprazole |
| D008795 | Metronidazole |
| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
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