Clinical Trials Directory

Trials / Completed

CompletedNCT03547544

Rapid Urease Test for Diagnosis Helicobacter Pylori Infection

Effectiveness of Rapid Urease Test (Helicotec) for The Diagnosis of Helicobacter Pylori Infection in Dyspepsia Patients in Endoscopy Centre

Status
Completed
Phase
Study type
Observational
Enrollment
97 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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®

Conditions

Timeline

Start date
2018-05-28
Primary completion
2018-12-31
Completion
2018-12-31
First posted
2018-06-06
Last updated
2023-10-06

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT03547544. Inclusion in this directory is not an endorsement.