Tailored H. Pylori Eradication Based on Clarithromycin Resistance

Study Overview
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Brief Summary
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The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

Detailed Description
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Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant. Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.

Official Title
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Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance

Conditions
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Helicobacter Pylori Infection, Antibiotic Resistant Strain

Intervention / Treatment
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* Drug: proton pump inhibitor, amoxicillin, clarithromycin
* Drug: proton pump inhibitor, amoxicillin, metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Helicobacter pylori infection Exclusion Criteria: H. pylori eradication therapy within 1 year, antibiotics within 4 weeks, surgery for gastric cancer malignant tumors other than gastric cancer end-stage renal disease liver cirrhosis, pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 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 |
| --- | --- |
| PAM-treated clarithromycin-resistance group<br>Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and metronidazole (500 mg) three times a day for 7 days in patients with clinically significant point mutations | Drug: proton pump inhibitor, amoxicillin, metronidazole<br>* clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole<br>|
| PAC-treated nonresistance group<br>Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and clarithromycin (500 mg) twice a day for 7 day in patients with clinically insignificant point mutations | Drug: proton pump inhibitor, amoxicillin, clarithromycin<br>* non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | Number of participant with successful Helicobacter pylori eradication | 2 year |