Helicobacter Pylori Eradication Study

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.

Detailed Description
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Purpose of Study> To evaluate the efficacy of tailored therapy compared to concomitant therapy. Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin. To evaluate the compliance of tailored therapy compared to concomitant. To analysis of factors which influence to the eradication rate. Patients> ; Target disease peptic ulcers(gastric ulcer, duodenal ulcer), gastric MALToma, Endoscopic therapy state of early gastric cancer or gastric adenoma, Patients who require H. pylori testing by clinical judgment, such as chronic gastritis. Method> Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. In concomitant treatment group, lansoprazole 30 mg, amoxicillin 1.0 g, metronidazole 500 mg and clarithromycin 500 mg were administered twice a day for 2 weeks, regardless of 23S ribosomal RNA point mutation. In tailored treatment group, In the case of 23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. In tailored treatment group, In point mutation positive cases, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. For each treatment group, at least 4 weeks after completion of drug administration, confirm the sterilization and confirm the compliance and adverse effects of the drug.

Official Title
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Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Lansoprazole 30mg
* Drug: Amoxicillin 1.0g Tab
* Drug: Clarithromycin 500mg
* Drug: Metronidazole 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H. pylori infection diagnosed patient, between 18 years old and 80 years old No history of H. pylori eradication therapy No antibiotic use for more than 3 days within 1 month of treatment Exclusion Criteria: History of taking antibiotics for more than 3 days in the last 1 month History of subtotal or partial gastrectomy Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality Pregnant and lactating women Disagree with the survey or do not respond to the questionnaire Contraindications for each medications

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: concomitant group<br>lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation. | Drug: Lansoprazole 30mg<br>* lansoprazole 30 mg tablet<br>* Other names: langton;Drug: Amoxicillin 1.0g Tab<br>* Amoxicillin 1.0g tablet<br>* Other names: amoxiclav;Drug: Clarithromycin 500mg<br>* Clarithromycin 500mg tablet<br>* Other names: clavacin;Drug: Metronidazole 500 mg<br>* Metronidazole 500 mg tablet<br>* Other names: lysinyl;|
| Experimental: tailored treatment group I<br>23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. | Drug: Lansoprazole 30mg<br>* lansoprazole 30 mg tablet<br>* Other names: langton;Drug: Amoxicillin 1.0g Tab<br>* Amoxicillin 1.0g tablet<br>* Other names: amoxiclav;Drug: Clarithromycin 500mg<br>* Clarithromycin 500mg tablet<br>* Other names: clavacin;|
| Experimental: tailored treatment group II<br>23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. | Drug: Lansoprazole 30mg<br>* lansoprazole 30 mg tablet<br>* Other names: langton;Drug: Clarithromycin 500mg<br>* Clarithromycin 500mg tablet<br>* Other names: clavacin;Drug: Metronidazole 500 mg<br>* Metronidazole 500 mg tablet<br>* Other names: lysinyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy. | Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy) | At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin | Identify the effect of 23S ribosomal RNA point mutation on the eradication rate regardless of the administration drug. | Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed. |