Recruitment

Recruitment Status
Completed

Inclusion Criterias

histologic evidence of H. pylori by modified Giemsa staining
positive 13C-urea breath test
Male and female Korean Adult (Aged ≥ 18 years)
...
histologic evidence of H. pylori by modified Giemsa staining
positive 13C-urea breath test
Male and female Korean Adult (Aged ≥ 18 years)
positive rapid urease test (CLOtest)

Exclusion Criterias

Other severe concurrent diseases
Previous allergic reactions to the study drugs
Age under 18 years
...
Other severe concurrent diseases
Previous allergic reactions to the study drugs
Age under 18 years
Pregnant or lactating women
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
Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
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 Criterias

histologic evidence of H. pylori by modified Giemsa staining
positive 13C-urea breath test
Male and female Korean Adult (Aged ≥ 18 years)
...
histologic evidence of H. pylori by modified Giemsa staining
positive 13C-urea breath test
Male and female Korean Adult (Aged ≥ 18 years)
positive rapid urease test (CLOtest)

Exclusion Criterias

Other severe concurrent diseases
Previous allergic reactions to the study drugs
Age under 18 years
...
Other severe concurrent diseases
Previous allergic reactions to the study drugs
Age under 18 years
Pregnant or lactating women
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
Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
History of gastrectomy

Locations

Seongnam-si, Gyeonggi-do, 463-707
Seongnam-si, Gyeonggi-do, 463-707

Tracking Information

NCT #
NCT02159976
Collaborators
  • SK Chemicals Co., Ltd.
  • Chong Kun Dang Pharmaceutical
  • HK inno.N Corporation
  • Green Cross Corporation
Investigators
Not Provided