An interventional study of triple therapy and quadruple therapy in Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation and Helicobacter Pylori Infection, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.
Empirical therapy is conventional triple therapy (proton pump inhibitor (PPI) standard dose, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days). Genotypic resistance-guided tailored therapy is the method which is chosen by DPO-PCR test. While the patients who have positive result of clarithromycin resistance receive the quadruple therapy(PPI standard dose, bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days), clarithromycin susceptible patients receive the triple therapy.
H. pylori is difficult to cultivate, cultivation of H. pylori and minimum inhibitory concentration test as a resistance test method are very difficult and take a long time. Recently, tailored treatment based on clarithromycin susceptibility has been proposed by dual-priming oligonucleotide-based multiplex (DPO)-PCR test. This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. This test is performed only by gastric biopsy. The examination time is also short as several hours, and sensitivity and specificity are about 80-85%.
Antibiotic resistance of H. pylori, especially clarithromycin resistance, is a cause of major failure of its eradication, and Korea 's clarithromycin resistance rate is reported to be about 37%. The eradication rate of standard triple therapy reported in Korea is also unsatisfactory as antibiotic resistance rate of H. pylori increases. The ideal eradication rate for H. pylori is approximately 90%, but in the meta-analysis of the recently reported primary eradication, the overall eradication rate was 74.6% in the intention to treat analysis.
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Exclusion Criteria:
Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days
Combination Product: triple therapy
Patients receive triple or quadruple therapy by resistance-associated mutations in 23S ribosomal RNA which are identified by polymerase chain reaction (PCR). Triple therapy contains esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days and quadruple therapy contains esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days.
Combination Product: triple therapy · Combination Product: quadruple therapy · Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test
esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days
esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days
Resistance of clarithromycin 23S rRNA point mutation
Eradication rate
Eradication rate of H. pylori infection
Time frame: 13C-UBT at least 4 weeks after completion of treatment
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital