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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter 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 Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

General population: Jakarta citizen Targeted population: Patients of endoscopy centre Cipto Mangunkusumo Hospital Sample: Targeted population who undergo endoscopy examination and met the inclusion and exclusion criteria

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Ari F Syam, Dr, MD, Gastroenterology Division, Internal Medicine Department RSCM/UI

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: helicobacter pylori; urease test; helicotec
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: 18-04-0394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No