Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.
Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan-based triple therapy group | Experimental | Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days) |
|
| Extended sequential therapy group | Active Comparator | Including patients receiving extended sequential therapy (lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan-based triple therapy | Drug | vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of helicobacter pylori | Assessed by urea breath test | Assessed at least 6 weeks after the therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of the drugs | Self-reported adverse effects by patients through a questionnaire. | After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy) |
| Compliance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yu-tse Chiu, MD | Fu Jen Catholic University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Jen Catholic University Hospital | New Taipei City | 243 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39164808 | Derived | Chiu YT, Lee FJ, Kuo CY, Chen YT, Lin YC, Liang KS, Wu CY, Lin RT, Lin JT, Chang CY. Seven-Day Vonoprazan-Based Triple Therapy as First-Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13129. doi: 10.1111/hel.13129. |
Not provided
Not provided
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository and are available on request for the use of academic research in relevant field after the study is published, in the form of excel file with de-identification (main contact: Chiu, Yu-tse, b95401030@gmail.com; consent from participants had been obtained).
IPD will be available on request for the use of academic research in relevant field after the study is published.
The purpose of obtaining the IPD should be for the use of academic research in relevant field.
Not provided
Not provided
| ID | Term |
|---|---|
| C039747 | ribosomal protein S14 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Extended sequential therapy | Drug | Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days |
|
|
Self-reported compliance by patients through a questionnaire.
| After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy) |