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In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups.
Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.
The investigators aim to evaluate the eradication success rate and treatment compliance between PPI and tegoprazan in first-line H. pylori treatment with adding bismuth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPI-BID group | Standard dose of PPI bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days | ||
| Tegoprazan-BID group | Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days | ||
| PPI-QID group | Standard dose of PPI bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days | ||
| Tegoprazan-QID group | Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid,tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rates | Urea breath test after completing H. pylori eradication regimen | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment compliance | Assessment of patients' numbers completing H. pylori eradication regimen | 6 weeks |
| Drug-related adverse event rate | Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment |
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Inclusion Criteria:
Exclusion Criteria:
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H. pylori-infected patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun-Hyung Cho | Contact | +82-2-709-9202 | 9581 | chojhmd@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun-Hyung Cho, M.D. | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Disease Center, Soonchunhyang University Hospital | Recruiting | Seoul | 04401 | South Korea |
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| 6 weeks |