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

Tracking Information

First Received Date ^ICMJE

September 29, 2011

Last Updated Date

May 7, 2012

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Helicobacter pylori eradication rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01453036 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Helicobacter Pylori Eradication Rate According to Clarithromycin Resistance

Official Title ^ICMJE

Helicobacter Pylori Eradication Rate According to 23S rRNA Point Mutations Associated Clarithromycin Resistance

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Peptic Ulcer
Helicobacter Pylori Infection

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Procedure: 23S rRNA point mutation test of Helicobacter pylori

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1232

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jin Il Kim, Professor

821063459977

jikim@catholic.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01453036

Other Study ID Numbers ^ICMJE

CUK

Has Data Monitoring Committee

Yes

Responsible Party

Jin Il Kim, The Catholic University of Korea

Study Sponsor ^ICMJE

Jin Il Kim

Collaborators ^ICMJE

Korean College of Helicobacter and Upper Gastrointestinal Research

Investigators ^ICMJE

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

Information Provided By

The Catholic University of Korea

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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