Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori

Chuncheon Sacred Heart Hospital112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Gastric Ulcer Associated With Helicobacter Pylori

Interventions

EndonaseDRUG

PPI- based triple therapy with endonase

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Male or Female with 18 years or more of age without history of H. pylori eradication AND 1. Patients with H. pylori associated peptic ulcer in scar stage, OR 2. Non-ulcer dyspepsia patients with H. pylori infection Exclusion Criteria: 1. Under 18 years, OR 2. Patients with a history of previous treatment of H. pylori infection, OR 3. Pregnant or Breast feeding women, OR 4. Patients with severe renal, liver, or heart disease, OR 5. Patients with gastric malignancy, OR 6. Patients with a history of drug allergy or hypersensitivity, OR 7. Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy

Locations (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Secondary Outcomes

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

Time frame: 4 weeks

Number of participants taking over 85% of medicine

Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment

Time frame: 4 weeks

Data from ClinicalTrials.gov

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