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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