Helicobacter Pylori Eradication
Conditions
Keywords
Helicobacter pylori, Eradication, minocycline, bismuth quadruple regimens
Brief summary
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
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.
Interventions
Antibiotic for H. pylori eradication
DRUGClarithromycin
Antibiotic for H. pylori eradication
DRUGAmoxicillin
Antibiotic for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
DRUGesomeprazole
Proton pump inhibitor
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate | 4-12 weeks after treatment | Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse effects | 3-7 days after treatment | incidence of adverse effects of minocycline-containing bismuth quadruple therapy |
Contacts
Primary ContactYan Li, master
Backup ContactYuehua Han, PhD
Outcome results
None listed