Clarithromycin Resistant Tailored Therapy

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

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

Sponsors & Collaborators

• Korean College of Helicobacter and Upper Gastrointestinal Research

  collaborator OTHER

• Jin Il Kim

  lead OTHER

Principal Investigators

• Hyun Jeong Lee, fellow · Yeouido St. Mary's Hospital, The Catholic University of Korea

• Dae Young Cheung, professor · Yeouido St. Mary's Hospital, The Catholic University of Korea

• Seong Su Kim, professor · The Catholic University of Korea

• Byeong Ug Kim · The Catholic University of Korea

• Tae Ho Kim · The Catholic University of Korea

• Eun Jung Jeon · The Catholic University of Korea

• Jung Hwan Oh, Professor · The Catholic University of Korea

• Woo Chul Chung, professor · The Catholic University of Korea

• Soo Heon Park · The Catholic University of Korea

• Jea Kwang Kim · The Catholic University of Korea

• Jin Il Kim · The Catholic University of Korea

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2012-06-30

Completion

2012-06-30

Countries

• South Korea

Study Locations