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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief 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.

Detailed Summary:
Sponsor: Seoul National University Bundang Hospital

Current Primary Outcome: Helicobacter pylori reinfection rate [ Time Frame: From date of randomization until the date of first documented reinfection of Helicobacter pylori, whichever came first, assessed up to 90 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Seoul National University Bundang Hospital

Dates:
Date Received: February 12, 2013
Date Started: January 2003
Date Completion:
Last Updated: February 14, 2013
Last Verified: February 2013