NCT02159976

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. 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. 2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Detailed 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 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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Pantoprazole	Pantoprazole 40mg bid
DRUG	Amoxicillin	Amoxicillin 1000mg bid
DRUG	Clarithromycin	Clarithromycin 500mg bid
DRUG	Metronidazole	Metronidazole 500mg tid
DRUG	Tetracycline	Tetracycline 1000mg bid
DRUG	Bismuth	Bismuth 600mg bid

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-05-01
• Completion: 2016-04-01
• First posted: 2014-06-10
• Last updated: 2019-05-13
• Results posted: 2019-05-13

Locations

1 site across 1 country: South Korea