The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori
Condition: Helicobacter Infection
MeSH terms: Helicobacter Infections
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): H. pylori culture and antimicrobial susceptibility test; 14 day PBMT group; 14 day MEA group
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute [amoxicillin (AMC), MIC ≥ 0.5 μg / ml; clarithromycin (CLA), MIC > 1.0 μ g / ml; metronidazole (MET), MIC > 8 μ g / ml; tetracycline (TC), MIC > 4 μ g / ml; and moxifloxacin (MOX), MIC > 1 μ g / ml).; Rescue therapy using 14 day PBMT regimen [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]; Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Personalized therapy; antimicrobial susceptibility; rescue therapy; culture