Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy as First-Line Regimen for Helicobacter Pylori Eradication

Conditions
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Helicobacter Pylori Eradication

Intervention / Treatment
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* Drug: Minocycline hydrochloride capsule
* Drug: Clarithromycin
* Drug: Amoxicillin
* Drug: colloidal bismuth pectin
* Drug: esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H.pylori-positive outpatients with endoscopically proven chronic gastritis H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining Treatment-naive patients for eradication of H.pylori infection Fully informed and agreed to participate in this study Exclusion Criteria: Age <18 years or >70 years Allergy to any of the study drugs Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA) Previous gastric or esophageal surgery Patients with malignancy or severe comorbidity Pregnancy,lactation or alcohol abuse Patients with poor treatment compliance or could not express themselves correctly Participation in other clinical studies recently (within 3 months of enrollment in this clinical study)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minocycline-based bismuth quadruple regimen for 14 days<br>Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. | Drug: Minocycline hydrochloride capsule<br>* Antibiotic for H. pylori eradication<br>* Other names: Meiman;Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: colloidal bismuth pectin<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: esomeprazole<br>* Proton pump inhibitor<br>|
| Active Comparator: clarithromycin-based bismuth quadruple regimen for 14 days<br>Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. | Drug: Clarithromycin<br>* Antibiotic for H. pylori eradication<br>* Other names: Klacid;Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: colloidal bismuth pectin<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: esomeprazole<br>* Proton pump inhibitor<br>|
| Experimental: minocycline-based bismuth quadruple regimen for 10 days<br>Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. | Drug: Minocycline hydrochloride capsule<br>* Antibiotic for H. pylori eradication<br>* Other names: Meiman;Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: colloidal bismuth pectin<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: esomeprazole<br>* Proton pump inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate | Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy | 4-12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse effects | incidence of adverse effects of minocycline-containing bismuth quadruple therapy | 3-7 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Eradication, minocycline, bismuth quadruple regimens