Clinical Trial: The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Efficacy of the Culture Based Tailored Therapy for Helicobacter Pylori Eradication Comparing With the Traditional 2nd Line Rescue Therapy in Korean
Brief Summary: As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidently. In this study, the investigators evaluated the efficacy of H. pylori eradication between a 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 traditional 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.
Detailed Summary: The patients who had shown the evidence of persistent H. pylori infection after the 1st eradication were enrolled for this study. After giving the informed consent about the method and efficacy (ITT and PP analysis) of the traditional 2nd rescue therapy and the tailored therapy for H. pylori infection based on culture and MIC, the patients were classified into the three regimen group under the patient's agreement and underwent 2nd eradication [14 days bismuth-based quadruple therapy (Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.), 14 days moxifloxacin-containing triple therapy (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.), or tailored therapy based on H. pylori culture and MIC (select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility)].This study was analyzed the success of eradication for enrolled participants retrospectively, however the patients were enrolled prospectively based on previous study about antimicrobial susceptibility test for H. pylori in Korea.
Sponsor: Seoul National University Bundang Hospital
Current Primary Outcome: Number of Participants in Each Arm/Group With Successful H. Pylori Eradication [ Time Frame: 6 weeks after completion of eradication ]
the efficacy of H. pylori eradication between a 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 traditional 2nd rescue regimens.
The eradication rate was evaluated by intention to treat (ITT)
Original Primary Outcome: Compare the percentage of participants with successful H. pylori eradication in each groups [ Time Frame: 6 weeks after completion of eradication ]
the efficacy of H. pylori eradication between a 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 traditional 2nd rescue regimens.
The eradication rate was evaluated by intention to treat (ITT) and per-protocol (PP) analysis
Current Secondary Outcome: Number of Participants in Each Arm/Group With Successful H. Pylori Eradication [ Time Frame: 6 weeks after completion of eradication ]
the efficacy of H. pylori eradication between a 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 traditional 2nd rescue regimens.
The eradication rate was evaluated by per-protocol analysis (PP)
Original Secondary Outcome:
Information By: Seoul National University Bundang Hospital
Dates:
Date Received: January 25, 2015
Date Started: January 2010
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016
