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NCT06684860
RUT vs. Molecular Testing for H. Pylori
trial in H.Pylori Infection in 100 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Soonchunhyang University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 November 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across South Korea |
Conditions studied
- H.Pylori Infection — all drugs for H.Pylori Infection →
Sponsor
Soonchunhyang University Hospital
Who can join
Adults 20 to 80, any sex, with H.Pylori Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The rapid urease test (RUT) is frequently performed for diagnosis of Helicobacter pylori infection in clinical practice. The RUT is a simple and inexpensive method that utilizes a commercial kit containing urea and a pH indicator such as phenol red. In the presence of H. pylori urease, urea is hydrolyzed to ammonia, which raises the pH of the medium, and changes the color of the kit from yellow to magenta or pink. The sensitivity and specificity of RUT were reported to range between 80-100% and 97-99%, respectively. When endoscopy is performed, RUT is known as the first-line method used for H. pylori diagnosis. However, RUT is an indirect test method, and has the disadvantage of causing false positivity due to other urease-producing bacteria. To date, gold standards for H. pylori diagnosis are culture and histological examination Because H. pylori is a rather fastidious and slow-growing bacterium, antimicrobial susceptibility testing using culture methods is time-consuming (10-14 days) and requires specific expertise. Recently, dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection. Moreover, molecular testing can identify point mutations related to clarithromycin resistance. It can be performed in a standard thermocycler and takes only 4 h to complete. The concordance rate between conventional clarithromycin susceptibility testing and DPO-PCR was excellent up to 95%. However, there was no comparison study between RUT and molecular testing for H. pylori diagnosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other recruiting trials for H.Pylori Infection
Currently open trials in the same condition.
- NCT07344506 — CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Erad · Phase 4 · recruiting
- NCT06950489 — Tegoprazan and Amoxicillin Dual Therapy · recruiting
- NCT06682533 — Tegoprazan- Versus PPI-based H. Pylori Eradication · recruiting
Other Soonchunhyang University Hospital trials
Trials by the same sponsor.
- NCT07213596 — Virtual Reality Treatment for Trauma Related to COVID-19 Infection · NA · not yet recruiting
- NCT06950489 — Tegoprazan and Amoxicillin Dual Therapy · recruiting
- NCT06682533 — Tegoprazan- Versus PPI-based H. Pylori Eradication · recruiting
- NCT06369896 — Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures · not yet recruiting
- NCT06431737 — Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06684860 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Soonchunhyang University Hospital
- Last refreshed: 29 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06684860.
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