Clarithromycin Resistant Tailored Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

924 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peptic Ulcer Helicobacter Pylori Infection

Keywords

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Peptic ulcer Helicobacter pylori Clarithromycin 23S rRNA Resistance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

UBT test & Gastroenterology with biopsy c silver stain

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

23S rRNA point mutation test of Helicobacter pylori

Intervention Type 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

UBT test & Gastroenterology with biopsy c silver stain

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

UBT test & Gastroenterology with biopsy c silver stain

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Jin Il Kim

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hyun Jeong Lee, fellow

Role: PRINCIPAL_INVESTIGATOR

Yeouido St. Mary's Hospital, The Catholic University of Korea

Dae Young Cheung, professor

Role: PRINCIPAL_INVESTIGATOR

Yeouido St. Mary's Hospital, The Catholic University of Korea