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Rapid Urease Test for Diagnosis Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT03547544
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ari Fahrial Syam, Indonesia University

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.


Condition or disease
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®

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Study Type : Observational
Estimated Enrollment : 97 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Effectiveness of Rapid Urease Test (Helicotec) for The Diagnosis of Helicobacter Pylori Infection in Dyspepsia Patients in Endoscopy Centre
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Effectivity of Helicotec [ Time Frame: 1 day ]
    Obtained the sensitivity and specificity value



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547544


Contacts
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Contact: Ari F Syam, Dr, MD +62818706199 ari_syam@hotmail.com

Locations
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Indonesia
Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Ari F Syam, Dr, MD    +62818706199    ari_syam@hotmail.com   
Principal Investigator: Ari F Syam, Dr, MD         
Sub-Investigator: Murdani Abdullah, Prof, MD         
Sub-Investigator: Dadang Makmun, Prof, MD         
Sub-Investigator: Hasan Maulahela, MD         
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Ari F Syam, Dr, MD Gastroenterology Division, Internal Medicine Department RSCM/UI

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Responsible Party: Ari Fahrial Syam, Staff of Gastroenterology Division, Internal Medicine Department, Indonesia University
ClinicalTrials.gov Identifier: NCT03547544     History of Changes
Other Study ID Numbers: 18-04-0394
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ari Fahrial Syam, Indonesia University:
helicobacter pylori
urease test
helicotec
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections