A Prospective, Single-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare the 14-day Bismuth Quadruple Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter as a Rescue 2nd Therapy.

NCT02359331 NA TERMINATED

As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidentally. In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14 days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Details

Lead sponsor	Seoul National University Bundang Hospital
Phase	NA
Status	TERMINATED
Enrolment	370
Start date	2014-08
Completion	2022-12-01

Conditions

• Helicobacter Infection

Interventions

• H. pylori culture and antimicrobial susceptibility testing
• 14 days empirical bismuth quadruple therapy (Proton pump inhibitor)
• Metronidazole
• Tetracycline
• tripotassium dicitrate bismuthate
• 7 days tailored therapy Proton Pump Inhibitor
• Moxifloxacin
• Amoxicillin

Primary outcomes

• Compare the percentage of participants with successful H. pylori eradication in each groups — 6 weeks after completion of eradication
  The efficacy of H. pylori eradication between a 7 days tailored therapy for H. pylori infection based on the results of antimicrobial resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14 days bismuth quadruple therapy as 2nd rescue regimens. The eradication rate was evaluated by intention to treat (ITT) and per-protocol (PP) analysis

Countries

South Korea