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Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy

NCT02126722 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2014-04-30

No results posted yet for this study

Summary

H. pylori infection is the most important causative agent of gastritis, and subsequent atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests such as the Clo test. However, treatment with proton pump inhibitors (PPI) impairs the diagnostic yeld of urease tests. The EndoFaster test (NISO BioMed, Turin, Italy) is a new technology that has the advantage, over conventional urease tests, of a real-time analysis of the gastric juice that can provide information regarding Helicobacter pylori infection and pH value of the gastric contents. A well designed clinical study is therefore warranted to fully assess the performance of the EndoFaster test in detecting H. pylori infection in patients treated with PPI. We aim to perform a clinical study in an adult population in United Kingdom in order to determine the diagnostic accuracy of the Endo Faster test compared to the Clo test, histological diagnosis and the faecal antigen test in evaluating H.pylori infection. Patients on PPI will undergo a gastroscopy with multiple biopsies and during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out. H. pylori faecal antigen test will also be performed and used as gold standard. Diagnostic accuracy of the different methods will be determined.

Conditions

  • Helicobacter Infections

Interventions

PROCEDURE

Gastroscopy

Gastroscopy with multiple biopsies will be performed in all patients enrolled

DEVICE

EndoFaster test

During the gastroscopy the EndoFaster test will be carried out in all patients enrolled.

OTHER

Clo test

During the gastroscopy the Clo test will be carried out in all patients enrolled.

OTHER

Faecal Helicobacter pylori antigen

On the day of the endoscopic procedure all the enrolled patients will bring a stool sample for the detection of Helicobacter pylori antigen.

Sponsors & Collaborators

  • Niso Biomed S.R.L.

    lead INDUSTRY

Principal Investigators

  • Cinzia Papadia, MD · Homerton University Hospital

  • Ray Shidrawi, MD · Homerton University Hospital

  • Marco Novelli, MD · University College, London

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126722 on ClinicalTrials.gov