Clarithromycin Resistant Tailored Therapy

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453036
• Other study ID #: CUK
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2011
• Last updated: July 31, 2013
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Peptic Ulcer

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Gastroenterology Clinic	Seoul	Yeouido-dong/Yeongdeungpo-gu

Sponsors (2)

Lead Sponsor	Collaborator
Jin Il Kim	Korean College of Helicobacter and Upper Gastrointestinal Research

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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 Gastroenter — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks	No