Tailored Therapy for Clarithromycin-Resistant H. Pylori

Overview

Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

Full Title of Study: “Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 30, 2020

Interventions

  • Drug: PAM
    • treatment with PPI, metonidazole, amoxicillin
  • Drug: PBMT
    • treatment with PPI, metonidazole, bismuth, tetracyclin

Arms, Groups and Cohorts

  • Active Comparator: PAM
    • treatment with PPI, metonidazole, amoxicillin
  • Active Comparator: PBMT
    • treatment with PPI, metonidazole, bismuth, tetracyclin

Clinical Trial Outcome Measures

Primary Measures

  • H. pylori eradication rate
    • Time Frame: 14 days
    • H. pylori eradication rate

Participating in This Clinical Trial

Inclusion Criteria

  • peptic ulcer disease – H. pylori gastritis – low grade MALT lymphoma Exclusion Criteria:

  • history of gastric cancer surgery – severe comorbidity (ESRD, LC) – hypersensitivity to drug – pregnancy

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kangdong Sacred Heart Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shin, Woon Geon, Woon Geon Shin – Kangdong Sacred Heart Hospital
  • Overall Official(s)
    • Woon Geon Shin, Principal Investigator, Kangdong Sacred Heart Hospital
  • Overall Contact(s)
    • Woon Geon Shin, 82-2-2225-2814, sgun9139@gmail.com

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