Clarithromycin Resistant Tailored Therapy

Jin Il Kim

Status and phase: Completed; Phase 4

Conditions: Peptic Ulcer; Helicobacter Pylori Infection

Treatments: Procedure: UBT test & Gastroenterology with biopsy c silver stain; Procedure: 23S rRNA point mutation test of Helicobacter pylori

Study type: Interventional

Funder types: Other

Identifiers

NCT01453036

CUK

Details and patient eligibility

About

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.

Enrollment: 924 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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924 participants in 3 patient groups

Conventional AOC group

Active Comparator group

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

Treatment:

Procedure: UBT test & Gastroenterology with biopsy c silver stain

Mutation test group

Active Comparator group

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

Treatment:

Procedure: UBT test & Gastroenterology with biopsy c silver stain

Procedure: 23S rRNA point mutation test of Helicobacter pylori

Conventional AOM group

Active Comparator group

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

Treatment:

Procedure: UBT test & Gastroenterology with biopsy c silver stain