Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-09-28

Brief Summary

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In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.

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Detailed Description

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Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.

Conditions

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Helicobacter Pylori Infection Family History of Stomach Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard triple therapy

7 day-PPI based standard triple therapy

Group Type ACTIVE_COMPARATOR

Standard triple therapy

Intervention Type DRUG

Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days

Bismuth quadruple therapy

10 day-bismuth quadruple therapy

Group Type ACTIVE_COMPARATOR

Bismuth quadruple therapy

Intervention Type DRUG

Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days

Interventions

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Standard triple therapy

Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days

Intervention Type DRUG

Bismuth quadruple therapy

Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days

Intervention Type DRUG

Other Intervention Names

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7-day PPI-based standard triple therapy 10-day Bismuth quadruple therapy

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 18 or more including following conditions

* Family history of gastric cancer
* Post endoscopic resection status for early gastric cancer or adenoma
* Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)
* Chronic gastritis
* Non-ulcer dyspepsia
* Healthy adults who want to receive H. pylori treatment
* H. pylori positive by urea breath test, histology, or rapid urease test

Exclusion Criteria

* History of H. pylori eradication therapy
* History of stomach operation
* Other organ cancer within 5 years
* Liver cirrhosis or Hepatic insufficiency
* Renal insufficiency
* Current treatment for serious medical condition which may hinder participation
* Contraindication or allergy history for H. pylori treatment regimens
* Mental incompetence to understand and sign informed consent
* Incompatible conditions to be included into the trial by investigators' decision
* Inability to provide an informed consent
* History of treatment for peptic ulcer disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes