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NCT03547544 Clinical Trial

Rapid Urease Test for Diagnosis Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03547544
Other study ID # 18-04-0394
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 28, 2018
Est. completion date December 31, 2018

Study information
Verified date October 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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®

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Indonesia Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectivity of Helicotec Obtained the sensitivity and specificity value 1 day
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