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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03547544

Enrollment

Registered

2018-06-06

Start date

2018-05-28

Completion date

2018-12-31

Last updated

2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

helicobacter pylori, urease test, helicotec

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®

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Effectivity of Helicotec	1 day	Obtained the sensitivity and specificity value

Countries

Indonesia

Outcome results