Rapid Urease Test for Diagnosis Helicobacter Pylori Infection

University of Indonesia (UI)

Status: Completed

Conditions: Helicobacter Pylori Infection

Study type: Observational

Funder types: Other

Identifiers

NCT03547544

18-04-0394

Details and patient eligibility

About

Nowadays, the gold standard examinations for diagnosing H. pylori infection are histopathology and culture examination. However, those examinations take long preparation so they are not suitable to be applied in daily practice. In progress, another examination is being developed to detect urease enzyme from tissue biopsy. It is relatively faster in diagnosing H. Pylori infection. Some commercial urease tests which are available in Indonesia are Helicotec® and Pronto Dry®.

This study aims to determine the effectivity of Helicotec® in diagnosing H. pylori infection. It is expected to be scientific evidence that can be used as the basis daily routine of urease test in diagnosing H. Pylori infection.

Full description

This study is a diagnostic study. There will be 97 dyspepsia patients who met the inclusion and exclusion criteria. They will answer the questionnaire about personal data and examined physically. They will also undergo endoscopy, biopsy, and urease test using Helicotec®

Enrollment: 97 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (18-55 years old),
• Diagnosed with dyspepsia,
• Indicated for endoscopy,
• Agreed to participate in the study and signed the informed consent.

Exclusion criteria

• Pregnancy and breastfeeding woman,
• Patients with alarm symptom,
• History taking of antibiotics (amoxicillin, clarithromycin, levofloxacin), H2 receptor antagonist, proton pump inhibitor, misoprostol, sucralfat, bismuth, NSAIDs, steroid, rheumatoid drug within the last 2 weeks.