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Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with Endonase | Experimental | Second-line quadruple therapy [PPI(pantoprazole 40mg, lansoprazole 30mg, esomeprazole 40mg, rabeprazole 20mg, omeprazole 20mg) Bid, tetracycline 500 mg QID, metronidazole 500mg Tid, tripotassium dicitrate bismuthate 300mg QID] plus 20,000 units of pronase (endonase), BID for 7 days |
|
| without Endonase | No Intervention | Second-line quadruple therapy [PPI(pantoprazole 40mg, lansoprazole 30mg, esomeprazole 40mg, rabeprazole 20mg, omeprazole 20mg) Bid, tetracycline 500 mg QID, metronidazole 500mg Tid, tripotassium dicitrate bismuthate 300mg QID] for 7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second-line quadruple therapy with endonase | Drug | Compare Second-line quadruple therapy w/o pronase (endonase) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the bismuth-containing quadruple therapy plus endonase as the second-line treatment with that of the bismuth-containing quadruple therapy | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Difference in the number of participants with adverse events between patients receiving bismuth-containing quadruple therapy plus endoase as the second-line treatment for H. pylori and patients receiving only bismuth-containing quadruple therapy | 4 weeks |
| Number of participants taking over 85% of medicine |
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Inclusion Criteria:
Patients with 18 years or more of age AND Patients who failed the standard proton pump inhibitor-based triple therapy for H. pylori
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JinBong Kim, MD | Chuncheon Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | 200-100 | South Korea |
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Difference in the number of participants taking over 85% of medicine between patients receiving bismuth-containing quadruple therapy plus endoase as the second-line treatment for H. pylori and patients receiving only bismuth-containing quadruple therapy |
| 4 weeks |