Rapid Urease Test for Diagnosis Helicobacter Pylori Infection

Completed

• Conditions: Helicobacter Pylori Infection

• Registration Number: NCT03547544
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed 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®

Study Timeline

• Study First Submitted: 2018-05-23
• Study Start: 2018-05-28
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-06
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectivity of Helicotec	1 day	Obtained the sensitivity and specificity value

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia