Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- histologic evidence of H. pylori by modified Giemsa staining
- Male and female Korean Adult (Aged ≥ 18 years)
- positive rapid urease test (CLOtest)
- ...
- histologic evidence of H. pylori by modified Giemsa staining
- Male and female Korean Adult (Aged ≥ 18 years)
- positive rapid urease test (CLOtest)
- positive 13C-urea breath test
Exclusion Criteria
- Other severe concurrent diseases
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- ...
- Other severe concurrent diseases
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- Previous eradication treatment for H. pylori
- Advanced gastric cancer or other malignancy
- Previous allergic reactions to the study drugs
- Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
- Age under 18 years
- Pregnant or lactating women
- History of gastrectomy
Summary
- Conditions
- Helicobacter Pylori Infection
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against cla...
Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea. In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.
Inclusion Criteria
- histologic evidence of H. pylori by modified Giemsa staining
- Male and female Korean Adult (Aged ≥ 18 years)
- positive rapid urease test (CLOtest)
- ...
- histologic evidence of H. pylori by modified Giemsa staining
- Male and female Korean Adult (Aged ≥ 18 years)
- positive rapid urease test (CLOtest)
- positive 13C-urea breath test
Exclusion Criteria
- Other severe concurrent diseases
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- ...
- Other severe concurrent diseases
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- Previous eradication treatment for H. pylori
- Advanced gastric cancer or other malignancy
- Previous allergic reactions to the study drugs
- Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
- Age under 18 years
- Pregnant or lactating women
- History of gastrectomy
Tracking Information
- NCT #
- NCT02159976
- Collaborators
- SK Chemicals Co., Ltd.
- Chong Kun Dang Pharmaceutical
- HK inno.N Corporation
- Green Cross Corporation
- Investigators
- Not Provided