Additive Effect of Endonase on Eradication Rate of Second Line Therapy for HP Infection

Chuncheon Sacred Heart Hospital

Status: Terminated

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Second-line quadruple therapy with endonase

Study type: Interventional

Funder types: Other

Identifiers

NCT01643785

CSHH Endonase2

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Patients Under 18 years, OR
2. Patients with active peptic ulcer, OR
3. Pregnant or Breast feeding women, OR
4. Patients with gastric malignancy, OR
5. Patients with a history of drug allergy or hypersensitivity, OR
6. Patients with severe renal, liver, or heart diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

with Endonase

Experimental group

Description:

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

Treatment:

Drug: Second-line quadruple therapy with endonase

without Endonase

No Intervention group

Description:

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