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Helicobacter Pylori Eradication Rate According to Clarithromycin Resistance

This study is currently recruiting participants.
Verified May 2012 by The Catholic University of Korea
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: May 7, 2012
Last verified: May 2012
History of Changes
  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
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Accuracy of polymerase chain reaction, Helicobacter pylori [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1232
Study Start Date: September 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional 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 2weeks
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
Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test group
Other Name: Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea

  Eligibility

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

Inclusion Criteria:

  • 20 - 80 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453036

Contacts
Contact: Jin Il Kim, Professor 821063459977 jikim@catholic.ac.kr

Locations
Korea, Republic of
Gastroenterology Clinic Recruiting
Seoul, Yeouido-dong/Yeongdeungpo-gu, Korea, Republic of, 150-713
Contact: Hyun Jeong Lee, fellow     821098273686     silver8044@catholic.ac.kr    
Principal Investigator: Hyun Jeong Lee, fellow            
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
  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
Last Updated: May 7, 2012
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
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013