Comparing two methods for diagnosing H. pylori infection
Comparative Diagnostic Performance of Rapid Urease Test Versus Molecular Testing for Diagnosis of Helicobacter Pylori
This study is testing which method, a quick color change test or a more advanced molecular test, works better to diagnose H. pylori infection in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Soonchunhyang University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06684860 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the diagnostic accuracy of the rapid urease test (RUT) and molecular testing for Helicobacter pylori infection. The RUT is a widely used, cost-effective method that detects the presence of H. pylori through a color change in a pH indicator. The study will also investigate clinical factors that may lead to discordant results between these two diagnostic methods. By evaluating the effectiveness of RUT against molecular testing, the study seeks to enhance the accuracy of H. pylori diagnosis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 80 who are undergoing gastroscopy and can have H. pylori testing and pathological analysis performed.
Not a fit: Patients with severe systemic diseases, advanced chronic liver disease, or those who have recently undergone gastric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of H. pylori diagnosis, leading to better treatment outcomes for patients.
How similar studies have performed: While the RUT is a common diagnostic method, the comparison with molecular testing is less frequently explored, making this study a potentially novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gastroscopy can be performed * H. pylori test and pathological analysis can be performed Exclusion Criteria: * Age \< 20 or \> 80 years * Anemia (serum hemoglobin level \< 10 g/dL) * Severe systemic disease * Advanced chronic liver disease * Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics * History of H. pylori eradication * Drug allergy to antibiotics * History of gastric surgery * Recent history of upper gastrointestinal bleeding
Where this trial is running
Seoul
- Digestive Disease Center, Soonchunhyang University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jun-Hyung Cho, M.D. — Soonchunhyang University Hospital
- Study coordinator: Jun-Hyung Cho, M.D.
- Email: chojhmd@naver.com
- Phone: +82-2-709-9202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.