Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection
NCT ID: NCT03361267
Last Updated: 2017-12-12
Study Results
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2017-12-30
2018-06-28
Brief Summary
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Detailed Description
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In the past, clarithromycin resistance was rarely observed in Korea, but the resistance rate has increased rapidly during the last 10 years, up to 37.3%.
As an alternative, Korean guidelines of Helicobacter pylori eradication in 2013 recommend that bismuth-containing antibiotics (not containing clarithromycin) should be considered in areas with high clarithromycin resistance as in Korea. However, there is a lack of research on the efficacy of bismuth-containing quadruple therapy as a 1st-line therapy. The aim of this prospectivce randomized study is to investingate the efficacy, conpliance, adverse events and cost-effectiveness between bismuth containing quadruple therapy and tailored therapy in areas with high clarithromycin resistance
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bismuth containing quadruple therapy
If CLO test is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days If CLO test is negative, no intervention is needed
CLO test
CLO test : negative --\> drop out CLO test : postive --\> bismuth containing quadruple therapy
tailored therapy
If H. pylori PCR is negative, no intervention is needed If H. pylori PCR is positive and mutation is negative, triple regimen (rabeprazole 20 mg bid, amoxacillin 1000 mg bid, clarithromycin 500mg bid) are prescribed for 7 days is given If H. pylori PCR is positive and mutation is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days is given
Helicobacter pylori PCR test
Clarithromycin resistance (-) Triple therapy (rabeprazole 20 mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid) for 7 days Clarithromycin resistance (+) Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 500 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) for 7 days
Interventions
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Helicobacter pylori PCR test
Clarithromycin resistance (-) Triple therapy (rabeprazole 20 mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid) for 7 days Clarithromycin resistance (+) Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 500 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) for 7 days
CLO test
CLO test : negative --\> drop out CLO test : postive --\> bismuth containing quadruple therapy
Eligibility Criteria
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Inclusion Criteria
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection
Exclusion Criteria
* Less than 18 years old
* With history of H. pylori infection treatment
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
18 Years
80 Years
ALL
No
Sponsors
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Inha University Hospital
OTHER
Responsible Party
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Inha University Hospital
Inha University Hospital
Locations
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Inha University Hospital
Incheon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Byoung WooK Bang, M.D. phD
Role: primary
Other Identifiers
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Inha helicobacter study
Identifier Type: -
Identifier Source: org_study_id