Clarithromycin Resistant Tailored Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer; Helicobacter Pylori Infection
• Intervention / Treatment: Procedure: UBT test & Gastroenterology with biopsy c silver stain; Procedure: 23S rRNA point mutation test of Helicobacter pylori

• Study Type: Interventional
• Enrollment (Actual): 924
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeouido-dong/Yeongdeungpo-gu
    • Seoul, Yeouido-dong/Yeongdeungpo-gu, Korea, Republic of, 150-713
      • Gastroenterology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Active Comparator: 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	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; Procedure: 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; Other Names: Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jin Il Kim
• Collaborators: Korean College of Helicobacter and Upper Gastrointestinal Research
• Investigators: Principal Investigator: 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; Principal Investigator: Jea Kwang Kim, The Catholic University of Korea; Study Chair: Jin Il Kim, The Catholic University of Korea

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): September 27, 2013
• Last Update Submitted That Met QC Criteria: July 31, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Resistance; Clarithromycin; Peptic ulcer; 23S rRNA
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Peptic Ulcer
• Other Study ID Numbers: CUK