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Completed

NCT Number: NCT02557932

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Triple Therapy

Drug

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

Other names: 7-day PPI-based standard triple therapy

bismuth quadruple therapy

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

Other names: 10-day Bismuth quadruple therapy

Primary outcomes

  1. H. pylori eradication rate

    Time frame: 8 weeks after H. pylori treatment

Secondary outcomes

  1. Complications of H. pylori treatment

    Time frame: 1 month after H. pylori treatment

  2. Compliance to H. pylori treatment

    Time frame: 1 month

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

    Time frame: 1 year after H. pylori treatment

  4. H. pylori reinfection rate

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

  5. Factors associated with H. pylori reinfection

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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 23, 2015
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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