Clarithromycin Resistant Tailored Therapy
- Conditions
- Peptic UlcerHelicobacter Pylori Infection
- Interventions
- Procedure: UBT test & Gastroenterology with biopsy c silver stainProcedure: 23S rRNA point mutation test of Helicobacter pylori
- Registration Number
- NCT01453036
- Lead Sponsor
- Jin Il Kim
- Brief Summary
1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
3. Material \& methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 924
- 20 - 75 years old
- Peptic ulcer (gastric ulcer, duodenal ulcer)
- Helicobacter pylori positive
- Major comorbidities
- Pregnancy
- History of Helicobacter pylori eradication
- History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional AOC group UBT test & Gastroenterology with biopsy c silver stain The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks Mutation test group 23S rRNA point mutation test of Helicobacter pylori Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Mutation test group UBT test & Gastroenterology with biopsy c silver stain Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Conventional AOM group UBT test & Gastroenterology with biopsy c silver stain The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
- Primary Outcome Measures
Name Time Method Helicobacter Pylori Eradication Rate 8 weeks Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gastroenterology Clinic
🇰🇷Seoul, Yeouido-dong/Yeongdeungpo-gu, Korea, Republic of