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| Name | Class |
|---|---|
| Hallym University Medical Center | OTHER |
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South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, this study did not explore the antibiotic resistance profile of Helicobacter pylori. And, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAMB group | Experimental | PAMB treatment (modified quadruple therapy) for 14 days |
|
| PMBT group | Active Comparator | PBMT treatment (bismuth-containing quadruple therapy) for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAMB treatment (modified quadruple therapy) | Drug | Randomly assign either as PAMB or PBMT group treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of eradication success | Eradication success means negative urea breath test done at least after 4 weeks from medication administration | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events related to eradication medication | Adverse events related to eradication medication | up to 4 weeks |
| Rate of compliance of eradication medication administration | Compliance (percentage of amount) of eradication medication administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang Seok Bang, MD, PhD | Hallym University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuncheon Sacred Heart hospital | Chuncheon | Gangwon-do | 24253 | South Korea |
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PAMB group (modified quadruple therapy) vs. PBMT group (bismuth-containing quadruple therapy)
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| PBMT treatment (bismuth-containing quadruple therapy) | Drug | Randomly assign either as PAMB or PBMT group treatment |
|
|
| up to 4 weeks |