Clarithromycin Resistant Tailored Therapy

This study has been completed.
Sponsor:
Collaborator:
Korean College of Helicobacter and Upper Gastrointestinal Research
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01453036
First received: September 29, 2011
Last updated: July 31, 2013
Last verified: July 2013
  Purpose
  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.

Condition Intervention Phase
Peptic Ulcer
Helicobacter Pylori Infection
Procedure: 23S rRNA point mutation test of Helicobacter pylori
Procedure: UBT test & Gastroenterology with biopsy c silver stain
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Helicobacter Pylori Eradication Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 924
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional AOC group
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
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
Active Comparator: Mutation test group
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
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
Other Name: Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea
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
Active Comparator: Conventional AOM group
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
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453036

Locations
Korea, Republic of
Gastroenterology Clinic
Seoul, Yeouido-dong/Yeongdeungpo-gu, Korea, Republic of, 150-713
Sponsors and Collaborators
Jin Il Kim
Korean College of Helicobacter and Upper Gastrointestinal Research
Investigators
Principal Investigator: Hyun Jeong Lee, fellow Yeouido St. Mary's Hospital, The Catholic University of Korea
Principal Investigator: Dae Young Cheung, professor Yeouido St. Mary's Hospital, The Catholic University of Korea
Principal Investigator: Seong Su Kim, professor The Catholic University of Korea
Principal Investigator: Byeong Ug Kim The Catholic University of Korea
Principal Investigator: Tae Ho Kim The Catholic University of Korea
Principal Investigator: Eun Jung Jeon The Catholic University of Korea
Principal Investigator: Jung Hwan Oh, Professor The Catholic University of Korea
Principal Investigator: Woo Chul Chung, professor The Catholic University of Korea
Principal Investigator: Soo Heon Park The Catholic University of Korea
Principal Investigator: Jea Kwang Kim The Catholic University of Korea
Study Chair: Jin Il Kim The Catholic University of Korea
  More Information

Publications:
Responsible Party: Jin Il Kim, professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01453036     History of Changes
Other Study ID Numbers: CUK
Study First Received: September 29, 2011
Results First Received: June 7, 2012
Last Updated: July 31, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Peptic ulcer
Helicobacter pylori
Clarithromycin
23S rRNA
Resistance

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Helicobacter Infections
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014