Helicobacter Pylori Infection, Family History of Stomach Cancer
Conditions
Keywords
PPI standard triple therapy, Bismuth quadruple therapy, Helicobacter
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.
Interventions
Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
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
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H. pylori eradication rate | 8 weeks after H. pylori treatment |
Secondary
| Measure | Time frame |
|---|---|
| Complications of H. pylori treatment | 1 month after H. pylori treatment |
| Compliance to H. pylori treatment | 1 month |
| 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 |
Countries
South Korea
Outcome results
None listed