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In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard triple therapy | Active Comparator | 7 day-PPI based standard triple therapy |
|
| Bismuth quadruple therapy | Active Comparator | 10 day-bismuth quadruple therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard triple therapy | Drug | Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rate | 8 weeks after H. pylori treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of H. pylori treatment | 1 month after H. pylori treatment | |
| Compliance to H. pylori treatment | 1 month | |
| H. pylori infection status at 1 year after H. pylori treatment |
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Inclusion Criteria:
Men and women aged 18 or more including following conditions
H. pylori positive by urea breath test, histology, or rapid urease test
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Il Ju Choi, M.D., Ph.D. | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33653284 | Derived | Kim YI, Lee JY, Kim CG, Park B, Park JY, Choi IJ. Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial. BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1. |
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|
| Bismuth quadruple therapy | Drug | Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days |
|
|
| 1 year after H. pylori treatment |
| H. pylori reinfection rate | 3 years after success of H. pylori eradication |
| Factors associated with H. pylori reinfection | 3 years after success of H. pylori treatment |