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Clarithromycin Resistant Tailored Therapy

Primary Purpose

Peptic Ulcer, Helicobacter Pylori Infection

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
23S rRNA point mutation test of Helicobacter pylori
UBT test & Gastroenterology with biopsy c silver stain
Sponsored by
Jin Il Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer focused on measuring Peptic ulcer, Helicobacter pylori, Clarithromycin, 23S rRNA, Resistance

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gastroenterology Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional AOC group

Mutation test group

Conventional AOM group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Helicobacter Pylori Eradication Rate
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.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2011
Last Updated
July 31, 2013
Sponsor
Jin Il Kim
Collaborators
Korean College of Helicobacter and Upper Gastrointestinal Research
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1. Study Identification

Unique Protocol Identification Number
NCT01453036
Brief Title
Clarithromycin Resistant Tailored Therapy
Official Title
Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jin Il Kim
Collaborators
Korean College of Helicobacter and Upper Gastrointestinal Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer, Helicobacter Pylori Infection
Keywords
Peptic ulcer, Helicobacter pylori, Clarithromycin, 23S rRNA, Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
924 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional AOC group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Mutation test group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Conventional AOM group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
23S rRNA point mutation test of Helicobacter pylori
Other Intervention Name(s)
Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
UBT test & Gastroenterology with biopsy c silver stain
Intervention Description
UBT test & Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention
Primary Outcome Measure Information:
Title
Helicobacter Pylori Eradication Rate
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Jeong Lee, fellow
Organizational Affiliation
Yeouido St. Mary's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dae Young Cheung, professor
Organizational Affiliation
Yeouido St. Mary's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong Su Kim, professor
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byeong Ug Kim
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tae Ho Kim
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eun Jung Jeon
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung Hwan Oh, Professor
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo Chul Chung, professor
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo Heon Park
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jea Kwang Kim
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Il Kim
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Gastroenterology Clinic
City
Seoul
State/Province
Yeouido-dong/Yeongdeungpo-gu
ZIP/Postal Code
150-713
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20571304
Citation
Cho DK, Park SY, Kee WJ, Lee JH, Ki HS, Yoon KW, Cho SB, Lee WS, Joo YE, Kim HS, Choi SK, Rew JS. [The trend of eradication rate of Helicobacter pylori infection and clinical factors that affect the eradication of first-line therapy]. Korean J Gastroenterol. 2010 Jun;55(6):368-75. doi: 10.4166/kjg.2010.55.6.368. Korean.
Results Reference
result
PubMed Identifier
18159172
Citation
Bang SY, Han DS, Eun CS, Kim JE, Ahn SB, Sohn JH, Jeon YC, Kang JO. [Changing patterns of antibiotic resistance of Helicobacter pylori in patients with peptic ulcer disease]. Korean J Gastroenterol. 2007 Dec;50(6):356-62. Korean.
Results Reference
result

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Clarithromycin Resistant Tailored Therapy

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