H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

Study Overview
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Brief Summary
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The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment. Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Detailed Description
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The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Official Title
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Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Drug: H. pylori eradication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastroscopy can be performed H. pylori test and pathological analysis can be performed Exclusion Criteria: Age < 20 or > 80 years Anemia (serum hemoglobin level < 10 g/dL) Severe systemic disease Advanced chronic liver disease Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics History of H. pylori eradication History of gastric surgery Recent history of upper gastrointestinal bleeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Modified quadruple therapy<br>pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days | Drug: H. pylori eradication<br>* Antimicrobial agents for H. pylori eradication<br>|
| Tailored eradication<br>pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 days | Drug: H. pylori eradication<br>* Antimicrobial agents for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori infection status | Rate of successful H. pylori eradication | 6 weeks |