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| Name | Class |
|---|---|
| Korean College of Helicobacter and Upper Gastrointestinal Research | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional AOC group | Active Comparator | 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 | Active Comparator | 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 |
|
| Conventional AOM group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23S rRNA point mutation test of Helicobacter pylori | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Clinic | Seoul | Yeouido-dong/Yeongdeungpo-gu | 150-713 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20571304 | Result | 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. | |
| 18159172 |
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Mutation test group ; Patients which are no detection of H. pyloriare were excluded
five hospitals affiliated with the Catholic University who visited from August 2011 to June 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Convential 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Convential AOC Group | amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence - 50%, expected dropout rate -15%, predicted eradication rate - 80%, significance level - 0.05, statistical power - 90% | Posted | Number | 95% Confidence Interval | percentage of participants | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Convential AOC Group | amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jin Il Kim | The Catholic University of Korea | +82-2-3779-2382 | jikim@catholic.ac.kr |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
|
| UBT test & Gastroenterology with biopsy c silver stain | Procedure | UBT test & Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention |
|
| Jea Kwang Kim | The Catholic University of Korea | Principal Investigator |
| Jin Il Kim | The Catholic University of Korea | Study Chair |
| 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. |
| BG002 | Convential AOM Group | The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
| OG002 | Convential AOM Group | The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks |
|
|
| 0 |
| 308 |
| 0 |
| 308 |
| EG001 | Convential AOM Group | 0 | 308 | 0 | 308 |
| EG002 | Mutation Test Group | 0 | 218 | 0 | 218 |
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| D013272 | Stomach Diseases |