Clarithromycin Resistant Tailored Therapy

Phase 4

Completed

• Conditions: Peptic Ulcer; Helicobacter Pylori Infection

• 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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-17
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2012-06-07
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-31
• Last Update Submitted: 2013-07-31
• Results First Posted: 2013-09-27
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 924

Inclusion Criteria

• 20 - 75 years old
• Peptic ulcer (gastric ulcer, duodenal ulcer)
• Helicobacter pylori positive

Exclusion Criteria

• 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

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.

Trial Locations

Locations (1)

Gastroenterology Clinic; 🇰🇷 Seoul, Yeouido-dong/Yeongdeungpo-gu, Korea, Republic of