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

National Cancer Center, Korea352 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

352

Conditions

Helicobacter Pylori Infection Family History of Stomach Cancer

Interventions

Standard triple therapyDRUG

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

Bismuth quadruple therapyDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

H. pylori eradication rate

Time frame: 8 weeks after H. pylori treatment

Secondary Outcomes

Complications of H. pylori treatment

Time frame: 1 month after H. pylori treatment

Compliance to H. pylori treatment

Time frame: 1 month

H. pylori infection status at 1 year after H. pylori treatment

Time frame: 1 year after H. pylori treatment

H. pylori reinfection rate

Time frame: 3 years after success of H. pylori eradication

Factors associated with H. pylori reinfection

Time frame: 3 years after success of H. pylori treatment

Data from ClinicalTrials.gov

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