Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PPI-based triple therapy with endonase 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. |
Drug: Endonase
PPI- based triple therapy with endonase
|
| No Intervention: PPI-based triple therapy 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) |
Outcome Measures
Primary Outcome Measures
- Eradication rate [4 weeks]
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
Secondary Outcome Measures
- Number of participants with adverse events [4 weeks]
Difference in the number of participants with adverse events between patients receiving standard triple therapy plus endonase and patients receiving control treatment
- Number of participants taking over 85% of medicine [4 weeks]
Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
Male or Female with 18 years or more of age without history of H. pylori eradication AND
-
Patients with H. pylori associated peptic ulcer in scar stage, OR
-
Non-ulcer dyspepsia patients with H. pylori infection
Exclusion Criteria:
-
Under 18 years, OR
-
Patients with a history of previous treatment of H. pylori infection, OR
-
Pregnant or Breast feeding women, OR
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Patients with severe renal, liver, or heart disease, OR
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Patients with gastric malignancy, OR
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Patients with a history of drug allergy or hypersensitivity, OR
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Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon | Korea, Republic of | 200-100 |
Sponsors and Collaborators
- Chuncheon Sacred Heart Hospital
Investigators
- Study Chair: Jin Bong Kim, MD, Department of Internal Medicine, Hallym university college of medicine
- Study Director: Yeon Soo Kim, MD, PhD., Department of Internal Medicine, Hallym University College of Medicine
- Principal Investigator: Chang Seok Bang, MD, Department of Internal Medicine, Hallym University of College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSHH Endonase 1
- CLDD 1