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OpenTrials
Completed

NCT Number: NCT01453036

Clarithromycin Resistant Tailored Therapy

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gastroenterology Clinic

Seoul, Yeouido-dong/Yeongdeungpo-gu, 150-713, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Primary outcomes

  1. Helicobacter Pylori Eradication Rate

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Jin Il Kim

Other

Collaborators

  • Korean College of Helicobacter and Upper Gastrointestinal Research

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2011
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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