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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy: Prospective Validation

Brief 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.

Detailed Summary:

Urease tests such as the Clo test for the diagnosis of Helicobacter pylori infection have been widely used because they are simple, cheap, and easy to carry out (1, 2). They can be performed during the endoscopic exam and give a relatively rapid result. However, treatment with proton pump inhibitors (PPI) may alter the result by changing the milieu where bacteria are present, especially in the antrum, by rendering it inhospitable with consequent decrease in the bacterial load. In addition, PPI themselves may have antiurease properties (3). Another reason for a false-negative result is the presence of intestinal metaplasia (4), which also corresponds to an inhospitable environment for Helicobacter pylori. EndoFaster test 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. Sensitivity, specificity, PPV and NPV of EndoFaster test for Helicobacter pylori infection resulted to be 98.5%, 87.6%, 84.4% and 98.8 %, respectively. This test may be more accurate than conventional urease tests in the diagnosis of Helicobacter pylori infection in subjects on PPI as indeed it should increase the analysed area, thereby allowing to evaluating the bacterial density in both the gastric antrum and corpus. No data are currently available about the performance of the EndoFaster test in subjects on PPI and a well-designed clinical study is warranted.

The main aim of our study is to conduct a comparative study with the NISO BioMed EndoFaster test, the urease-based test (Clo test), histologic diagnosis and the faecal antigen test (used as the gold standard) for the diagnosis of Helicobacter pylori infection in PPI-treated patients.

We will perform a clinical study using the
Sponsor: Niso Biomed S.R.L.

Current Primary Outcome: Diagnostic accuracy of the EndoFaster test in H. pylori diagnosis [ Time Frame: Six weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Niso Biomed S.R.L.

Dates:
Date Received: April 28, 2014
Date Started: June 2014
Date Completion: March 2015
Last Updated: April 28, 2014
Last Verified: April 2014