RUT vs. Molecular Testing for H. Pylori

NCT ID: NCT06684860

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

The investigators aim to compare the diagnostic accuracy of the RUT and molecular testing, and identify clinical factors associated with the discordant results between the two methods.

Conditions

H.Pylori Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RUT group

The rapid urease test (RUT) was performed for diagnosis of H. pylori infection.

No interventions assigned to this group

Molecular test group

DPO-PCR testing was performed for diagnosis of H. pylori infection.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soonchunhyang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun-Hyung Cho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun-Hyung Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jun-Hyung Cho, M.D.

Role: CONTACT

chojhmd@naver.com

+82-2-709-9202 ext. 9581

Facility Contacts

Jun-Hyung Cho, M.D.

Role: primary

chojhmd@naver.com

+82-2-709-9202

Other Identifiers

SCH-HP-2024-12

Identifier Type: -

Identifier Source: org_study_id