Tailored H. Pylori Eradication Based on Clarithromycin Resistance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

431 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Helicobacter Pylori Infection Antibiotic Resistant Strain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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PAM-treated clarithromycin-resistance group

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

proton pump inhibitor, amoxicillin, metronidazole

Intervention Type DRUG

clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

PAC-treated nonresistance group

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

proton pump inhibitor, amoxicillin, clarithromycin

Intervention Type DRUG

non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin

Interventions

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proton pump inhibitor, amoxicillin, clarithromycin

non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin

Intervention Type DRUG

proton pump inhibitor, amoxicillin, metronidazole

clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No