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Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.
The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S3 | Active Comparator | Standard clarithromycin triple |
|
| V3 | Experimental | Vonoprazan triple |
|
| V2 | Experimental | Vonoprazan dual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard Clarithromycin triple therapy | Drug | Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the eradication rates for each regimen | Percentage eradication in each group is calculated by intention-to-treat analysis or per-protocol analysis. | 1.5 month |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of number of compliant participants to each regimen | Adherence to therapies is determined through pill count in medication boxes In addition to reviewing a daily medication schedule filled by the participant. | 1.5 month |
| Determination of number of participants with treatment related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University outpatient clinics | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40341536 | Derived | Shekeban YM, Hamdy NA, Header DA, Ahmed SM, Helmy MM. Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial. Sci Rep. 2025 May 8;15(1):15989. doi: 10.1038/s41598-025-98606-8. |
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Open-labeled, prospective, three-arm, parallel-group, non-placebo Randomized controlled clinical trial
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| Vonoprazan triple therapy | Drug | Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days |
|
| Vonoprazan dual therapy | Drug | Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days |
|
Patients will be contacted on a regular basis to monitor any reported adverse events |
| 2 weeks |