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Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.
A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minocycline-based bismuth quadruple regimen for 14 days | Experimental | Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. |
|
| clarithromycin-based bismuth quadruple regimen for 14 days | Active Comparator | Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. |
|
| minocycline-based bismuth quadruple regimen for 10 days | Experimental | Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline hydrochloride capsule | Drug | Antibiotic for H. pylori eradication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy | 4-12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse effects | incidence of adverse effects of minocycline-containing bismuth quadruple therapy | 3-7 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Li, master | Contact | 15906698496 | liyan_8786@zju.edu.cn | |
| Yuehua Han, PhD | Contact | 13858126927 | 13858126927@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Du, master | 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China | Principal Investigator |
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|
| Clarithromycin | Drug | Antibiotic for H. pylori eradication |
|
|
| Amoxicillin | Drug | Antibiotic for H. pylori eradication |
|
| colloidal bismuth pectin | Drug | Gastric mucosal protective drug with anti-H. pylori effect |
|
| esomeprazole | Drug | Proton pump inhibitor |
|
| ID | Term |
|---|---|
| C562573 | cyclopia sequence |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
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