NCT01792700

Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 648 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 23 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.

Conditions

• Helicobacter Infections

Interventions

Type	Name	Description
DRUG	esomeprazole
DRUG	tripotassium dicitrate bismuthate
DRUG	metronidazole
DRUG	tetracycline
DRUG	moxifloxacin
DRUG	amoxicillin

Timeline

• Start date: 2003-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2013-02-15
• Last updated: 2013-02-15

Locations

1 site across 1 country: South Korea