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Comparison of Sensitivity and Specificity of Helicobacter pylori Detection Kit with Urease Enzyme Using Nucleic Acid Isothermal Amplification assay; Prospective and Observational study

Comparison of Sensitivity and Specificity of Helicobacter pylori Detection Kit with Urease Enzyme Using Nucleic Acid Isothermal Amplification assay; Prospective and Observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0002668
Enrollment
900
Registered
2018-01-26
Start date
2016-06-08
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Daegu Fatima Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female over 18 years old 2. Those who want to perform upper gastrointestinal endoscopy 3. Patients who voluntarily signed written consent

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The association of 2143G and 2182C mutation of 23S rRNA of Helicobacter pylori with the eradication failure in clarithromycin-based triple therapy

Secondary

MeasureTime frame
The eradication success rate of 2nd line regimen in patients of treatment failure with 1st line clarithromycin-based triple therapy of H. pylori

Countries

Korea, Republic of

Contacts

Public ContactSeungWoo Han

Daegu Fatima Hospital

kiefe73@gmail.com+82-53-940-7013

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026