Clinical trial NCT02557932: Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Family History of Stomach Cancer
Keywords: PPI standard triple therapy
Bismuth quadruple therapy
Helicobacter
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-09-23
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: 8 weeks after H. pylori treatment
Secondary outcomes:
measure: Complications of H. pylori treatment
timeFrame: 1 month after H. pylori treatment
measure: Compliance to H. pylori treatment
timeFrame: 1 month
measure: H. pylori infection status at 1 year after H. pylori treatment
timeFrame: 1 year after H. pylori treatment
measure: H. pylori reinfection rate
timeFrame: 3 years after success of H. pylori eradication
measure: Factors associated with H. pylori reinfection
timeFrame: 3 years after success of H. pylori treatment
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Il Ju Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YI, Lee JY, Kim CG, Park B, Park JY, Choi IJ. Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial. BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1.