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Clarithromycin Resistant Tailored Therapy

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ClinicalTrials.gov Identifier: NCT01453036
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance
Study Start Date : August 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Helicobacter Pylori Eradication Rate [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 17, 2011    Key Record Dates
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Peptic Ulcer
Helicobacter Infections
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors