NCT01453036

Clarithromycin Resistant Tailored Therapy

Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 924 (actual)
• Sponsor: Jin Il Kim · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peptic Ulcer
• Helicobacter Pylori Infection

Interventions

Type	Name	Description
PROCEDURE	23S rRNA point mutation test of Helicobacter pylori	mutation test group\>\> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group \>\> no intervention
PROCEDURE	UBT test & Gastroenterology with biopsy c silver stain	UBT test \& Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group \>\> intervention

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-10-17
• Last updated: 2013-09-27
• Results posted: 2013-09-27

Locations

1 site across 1 country: South Korea