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| ID | Type | Description | Link |
|---|---|---|---|
| CLDD 1 | Other Identifier | CSHH CLDD 1 |
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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 eradication therapy against Helicobacter pylori.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPI-based triple therapy with endonase | Experimental | 7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) plus 20,000 units of endonase twice daily for one week. |
|
| PPI-based triple therapy | No Intervention | 7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endonase | Drug | PPI- based triple therapy with endonase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the 7-day standard PPI-based triple therapy plus endonase with that of the 7-day standard PPI-based triple 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 standard triple therapy plus endonase and patients receiving control treatment | 4 weeks |
| Number of participants taking over 85% of medicine |
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Inclusion Criteria:
Male or Female with 18 years or more of age without history of H. pylori eradication AND
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Bong Kim, MD | Department of Internal Medicine, Hallym university college of medicine | Study Chair |
| Yeon Soo Kim, MD, PhD. | Department of Internal Medicine, Hallym University College of Medicine | Study Director |
| Chang Seok Bang, MD | Department of Internal Medicine, Hallym University of College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | 200-100 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25167799 | Derived | Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ. Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection. Gut Liver. 2015 May 23;9(3):340-5. doi: 10.5009/gnl13399. |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment |
| 4 weeks |
| D013272 | Stomach Diseases |