NCT04558502

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 339 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori Eradication

Interventions

Type	Name	Description
DRUG	Minocycline hydrochloride capsule	Antibiotic for H. pylori eradication
DRUG	Clarithromycin	Antibiotic for H. pylori eradication
DRUG	Amoxicillin	Antibiotic for H. pylori eradication
DRUG	colloidal bismuth pectin	Gastric mucosal protective drug with anti-H. pylori effect
DRUG	esomeprazole	Proton pump inhibitor

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-06-05
• Completion: 2022-12-05
• First posted: 2020-09-22
• Last updated: 2022-01-13