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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Helicobacter Pylori Infection, Family History of Stomach Cancer

Intervention / Treatment
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* Drug: Standard triple therapy
* Drug: Bismuth quadruple therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard triple therapy<br>7 day-PPI based standard triple therapy | Drug: Standard triple therapy<br>* Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days<br>* Other names: 7-day PPI-based standard triple therapy;|
| Active Comparator: Bismuth quadruple therapy<br>10 day-bismuth quadruple therapy | Drug: Bismuth quadruple therapy<br>* 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<br>* Other names: 10-day Bismuth quadruple therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate |  | 8 weeks after H. pylori treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPI standard triple therapy, Bismuth quadruple therapy, Helicobacter