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The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.
This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure. For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin. The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clarithromycin-sensitive(first-line) | Experimental | If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days |
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| clarithromycin-resistant(first-line) | Experimental | If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment. HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days. |
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| empirical therapy group first-line | Active Comparator | The empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days. |
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| levofloxacin-sensitive(rescue treatment) | Experimental | If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clarithromycin-sensitive(first-line) | Drug | esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| the first-line H. pylori eradication rate | the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group. | 4-8 weeks after the end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| the rescue H. pylori eradication rate | The second line eradication rate between SGT and ET group. | 4-8 weeks after the second treatment |
| the overall H.pylori eradication rate | the total H.pylori eradication rate (first-line and second-line)between SGT and ET group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing run Zhao, Dr | Contact | +86-635-8276373 | zhjrun77@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing run Zhao, Dr | Liaocheng People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaocheng people's hospital | Recruiting | Liaocheng | Shandong | 252000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42144812 | Derived | Lu K, Zou X, Lang C, Zang L, Yang X, Sang W, Wang J, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-Guided Versus Empirical Therapy for Helicobacter pylori Infection in a High Resistance Setting: A Randomised Controlled Trial. Microbiologyopen. 2026 Jun;15(3):e70313. doi: 10.1002/mbo3.70313. | |
| 37337241 | Derived |
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| levofloxacin-resistant(rescue treatment) | Experimental | If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days. |
|
| empirical therapy group rescue treatment | Active Comparator | If BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days. |
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| clarithromycin-resistant(first-line) | Drug | esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days |
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| empirical therapy group first-line | Drug | esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days |
|
|
| levofloxacin-sensitive(rescue treatment) | Drug | esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days |
|
|
| levofloxacin-resistant(rescue treatment) | Drug | esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days |
|
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| empirical therapy group rescue treatment | Drug | esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days |
|
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| 4-8 weeks after the second treatment |
| high-dose dual therapy eradication rate | compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group. | 4-8 weeks after the second treatment |
| Adverse events and compliance | 3 days after the completion of therapy according to a data collection form | 3 days after the end of treatment. |
| Lu K, Lang C, Zou X, Zang L, Sang W, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-guided sequential strategy versus empirical therapy for Helicobacter pylori infection: study protocol for a randomised controlled trial. Trials. 2023 Jun 19;24(1):413. doi: 10.1186/s13063-023-07457-z. |