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

Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial

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.

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