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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empirical group | Placebo Comparator | Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days |
|
| Genotypic resistance-guided tailored group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triple therapy | Combination Product | esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Eradication rate of H. pylori infection | 13C-UBT at least 4 weeks after completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-Jeong Cho, M.D., ph.D. | Department of Internal Medicine and Liver Research Institute, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33094958 | Derived | Kim JL, Cho SJ, Chung SJ, Lee A, Choi J, Chung H, Kim SG. Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2020 Sep;11(9):e00194. doi: 10.14309/ctg.0000000000000194. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2019 | |
| Reset | Oct 10, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2019 | Oct 10, 2019 |
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| quadruple therapy | Combination Product | esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days |
|
| dual-priming oligonucleotide-based multiplex (DPO)-PCR test | Diagnostic Test | Resistance of clarithromycin 23S rRNA point mutation |
|