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

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection; Family History of Stomach Cancer
• Interventions: Drug: Standard triple therapy; Drug: Bismuth quadruple therapy

• Registration Number: NCT02557932
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-23
• Primary Completion: 2018-12
• Study Completion: 2019-09-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard triple therapy	Standard triple therapy	7 day-PPI based standard triple therapy
Bismuth quadruple therapy	Bismuth quadruple therapy	10 day-bismuth quadruple therapy

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	8 weeks after H. pylori treatment

Secondary Outcome Measures

Name	Time	Method
H. pylori infection status at 1 year after H. pylori treatment	1 year after H. pylori treatment
H. pylori reinfection rate	3 years after success of H. pylori eradication
Factors associated with H. pylori reinfection	3 years after success of H. pylori treatment
Compliance to H. pylori treatment	1 month
Complications of H. pylori treatment	1 month after H. pylori treatment

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of