Helicobacter Pylori Eradication According to DPO-PCR Methods

Study Overview
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Brief Summary
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Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin is increasing. Recent studies show that examining genotype resistance is effective in eradication. Currently dual priming oligonucleotide-polymerase chain reaction (DPO-PCR) is used to measure clarithromycin resistance. There has been no study of comparing the duration of eradication regimens according to DPO-PCR results. The aim of this study is to compare the eradication rate of 7- day triple therapy with 14-day triple therapy in clarithromycin susceptible strains from DPO-PCR. The investigators also aimed to compare the eradication rates of 7-day bismuth quadruple therapy with 14-day bismuth quadruple therapy from clarithromycin resistant strains from DPO-PCR.

Detailed Description
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This is a multi-center study perform at three tertiary university hospitals. Patients with H. pylori infection will be treated according to their DPO-PCR results. Patients who are susceptible to clarithromycin will be randomized to receive either triple therapy for 7-days or 14-days. Patients who are resistant to clarithromycin will be randomized to receive either bismuth quadruple therpay for 7-days or 14-days. The eradication rates of each regimens and the adverse events of each regimen will be investigated.

Official Title
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Helicobacter Pylori Eradication According to DPO-PCR Methods: Duration of Triple Therapy and Bismuth Quadruple According to Clarithromycin Resistance Patterns

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Duration of eradication regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination. Participants who voluntarily want to participate in this study. Exclusion Criteria: History of H. pylori eradication History of stomach resection. Allergy or adverse events related to eradication medication. Administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week. Administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate Administration of antibiotics within 4 weeks. Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial Administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor) Infectious mononucleosis Central nervous system infection Hematologic disease Galactose intolerance Lactase deficiency Glucose-galactose malabsorption Torsades de pointes.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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
Interventional Model Description: 7-day triple therapy vs. 14-day triple therapy for clarithromycin sensitive patients 7-day bismuth quadruple therapy vs. 14-day bismuth quadruple therapy for clarithromycin resistant patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7-day triple therapy and 7-day bismuth quadruple therapy<br>7-day triple therapy is consisted of proton pump inhibitor (PPI), amoxicillin and clarithromycin for seven days 7-day bismuth quadruple therapy is consisted of PPI, bismuth, tetracycline, metronidazole for seven days | Drug: Duration of eradication regimen<br>* 14 day eradication regimen<br>* Other names: 14 day treatment;|
| Active Comparator: 14-day triple therapy and 14-day bismuth quadruple therapy<br>14-day triple therapy is consisted of PPI, amoxicillin and clarithromycin for fourteen days 14-day bismuth quadruple therapy is consisted of PPI, bismuth, tetracycline, metronidazole for fourteen days | Drug: Duration of eradication regimen<br>* 14 day eradication regimen<br>* Other names: 14 day treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate | Negative urea breath test done | At least 4 weeks from eradication regimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Development of adverse events | Within one week from eradication administration |