Helicobacter Pylori Eradication Rate According to Clarithromycin Resistance
This study is currently recruiting participants.
Verified May 2012 by The Catholic University of Korea
Sponsor:
Jin Il Kim
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
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Purpose
- 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
- 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
- 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
Drug Information available for:
Clarithromycin
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:
|
Duodenal Diseases Peptic Ulcer Ulcer Helicobacter Infections 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 May 19, 2013