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To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Vonoprazan 20mg twice a day + clarithromycin 500mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days | Drug | Participants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of H. pylori | H. pylori eradication rate assessed by¹³C-urea breath test at 4 weeks after the completion of treatment. | 4 weeks after the completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse reactions | The incidence of adverse reactions refers to the proportion of participants who experience any adverse reactions related to the study drugs (vonoprazan and clarithromycin) during the 14-day medication period. | At the end of the 14-day medication period (Day 14) |
| Compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weihong Wang, MD, PhD | Contact | 13041171610 | wangweihong2581@163.com | |
| Meng Li | Contact | 18612034366 | dr_limeng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weihong Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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Medication compliance rate (proportion of participants with good compliance, defined as compliance rate ≥ 80%). |
| At the end of the 14-day medication period (Day 14) |
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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