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

National Cancer Center (NCC)

Status and phase

Completed

Phase 3

Conditions

Family History of Stomach Cancer

Helicobacter Pylori Infection

Treatments

Drug: Standard triple therapy

Drug: Bismuth quadruple therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02557932

NCC2015-0207

Details and patient eligibility

About

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.

Full 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.

Enrollment

352 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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