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Randomized Controlled Trial
. 2017 Nov 17;18(1):549.
doi: 10.1186/s13063-017-2281-0.

Concomitant, sequential, and 7-day triple therapy in first-line treatment of Helicobacter pylori infection in Korea: study protocol for a randomized controlled trial

Hyuk Lee  1 , Beom Jin Kim  2 , Sang Gyun Kim  3 , Jin Il Kim  4 , Il Ju Choi  5 , Yong Chan Lee  6 , Jae G Kim  7 , Jae J Kim  8 ; Korean College of Helicobacter and Upper Gastrointestinal Research
Affiliations
Randomized Controlled Trial

Concomitant, sequential, and 7-day triple therapy in first-line treatment of Helicobacter pylori infection in Korea: study protocol for a randomized controlled trial

Hyuk Lee et al. Trials. .

Erratum in

Abstract

Background: Most international guidelines recommend triple-therapy regimens consisting of a proton pump inhibitor, clarithromycin, and amoxicillin/metronidazole for at least 7 days for the eradication of Helicobacter pylori. However, the efficacy of 7-day clarithromycin-based standard triple therapy for H. pylori infection is currently unacceptable in Korea. In this study, we will compare the efficacy and safety of 7-day standard triple therapy, 10-day sequential therapy, and 10-day concomitant therapy for the first-line treatment of H. pylori infection in Korea.

Methods/design: In this multicenter, investigator-blinded, randomized trial we are recruiting adult patients with H. pylori infection from 15 hospitals in Korea to determine whether sequential or concomitant treatment is superior to standard triple therapy. Patients are randomly assigned to receive either standard triple therapy (lansoprazole, amoxicillin, and clarithromycin) for 7 days, or sequential treatment (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin, and metronidazole for another 5 days) for 10 days, or concomitant therapy (lansoprazole, amoxicillin, clarithromycin, and metronidazole) for 10 days. The primary outcome is the rate of H. pylori eradication in the intention-to-treat population.

Discussion: The results of this study will be crucial for determining the optimal regimen for the primary treatment of H. pylori infection in Korea. This study will produce vital evidence that will lead to revisions to guidelines concerning first-line treatment regimens for H. pylori infection.

Trial registration: Clinical Research Information Service (CRIS), Republic of Korea, KCT0001980 . Registered on 25 July 2016.

Keywords: Concomitant therapy; Helicobacter pylori; Sequential therapy; Triple therapy.

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The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Map showing the geographic locations of the 15 participating study centers in Korea
Fig. 2
Fig. 2
Study design
Fig. 3
Fig. 3
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure
See this image and copyright information in PMC

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