Comparison of Sensitivity and Specificity of Helicobacter pylori Detection Kit with Urease Enzyme Using Nucleic Acid Isothermal Amplification assay; Prospective and Observational study
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002668
- Lead Sponsor
- Daegu Fatima Hospital
- Brief Summary
We studied whether the point mutations in domain V of 23S rRNA can affect the eradication failure of H. pylori in prospective, open-label, and observation study. Among enrolled 755 patients, CLO test was positive in 299 patients (39.6%). DNA sequencing analysis of H. pylori 23S rRNA conducted in 295 patients revealed that 2143G point mutation was most frequently found in 24.7% of patients, followed by 2182T mutation in 11.5%. The overall eradication failure rate was 20.9% (42/201) in clarithromycin-based triple-therapy. The patients with 2143G allele had about 60% of eradication failure rate, suggesting a high risk allele of eradication failure. Patients with 2182C without 2143G had 8.7 % of failure rate and without both 2143G and 2182C had only 4.3% of failure rate. The presence of 2143G that was associated with previous eradication history and female sex was independent risk factor for eradication failure. In conclusion, the 2143G point mutation in 23S rRNA of H. pylori was independent risk factor for eradication failure in clarithromycin-based triple-therapy. Personalized tailored therapy based on genotypes of 23S rRNA can increase an eradication success rate in H. pylori infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 900
1. Male or female over 18 years old
2. Those who want to perform upper gastrointestinal endoscopy
3. Patients who voluntarily signed written consent
1. Patients who are deemed inappropriate to participate in this clinical study under the researcher's judgment for other serious diseases or disorders
2. Patients who are unable to understand and comply with consent (eg, mental deficiency, illiteracy, etc.)
3. Patients with a DNA extraction concentration of 50ng/ul or less
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The association of 2143G and 2182C mutation of 23S rRNA of Helicobacter pylori with the eradication failure in clarithromycin-based triple therapy
- Secondary Outcome Measures
Name Time Method The eradication success rate of 2nd line regimen in patients of treatment failure with 1st line clarithromycin-based triple therapy of H. pylori