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Completed

NCT Number: NCT03547544

Rapid Urease Test for Diagnosis Helicobacter Pylori Infection

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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®

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Effectivity of Helicotec

    Time frame: 1 day

    Obtained the sensitivity and specificity value

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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