About this trial
To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The patients who proved H. pylori infection following three methods
positive rapid urease test (CLOtest)
histologic evidence of H. pylori by modified Giemsa staining
positive Urea breath test
Disqualifiers
Patients who received eradication therapy for H. pylori infection, previously
H. pylori eradication failure because of poor compliance
the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
Advanced gastric cancer or other malignancy
Trial design
Parallel
Treatments tested in this trial
10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)
DrugIn this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10).
7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)
Drugthe participants received PPI based triple therapy\[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\]
7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]
Drugmoxifloxacin triple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)\].
7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)
Drugbismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\], bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)\] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.
Treatment groups
Trial outcomes
Primary outcomes
Compare the percentage of participants with successful H. pylori eradication in each groups
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 10 days therapy as first eradication regimen.
Sponsors and contacts
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