MedDataX Logo

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

NCT ID: NCT02126722

Last Updated: 2014-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 NISO BioMed Endofaster test to diagnose Helicobacter pylori infection in patients on PPI therapy. The study will be conducted as a collaboration between NISO BioMed (Turin, Italy) and Homerton University Hospital (London, UK). The study will be performed at the Homerton Hospital.

One hundred patients on PPI will be enrolled among the patients with dyspepsia referred for gastroscopy at Homerton University Hospital (London, United Kingdom). A control group of 50 patients with dyspepsia, not on PPI, will be also enrolled in the study.

On the day of the endoscopic procedure the patients will bring a stool sample for the detection of Helicobacter pylori antigen. Subsequently, a gastroscopy with multiple biopsies will be performed and during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out.

Directed biopsies will be collected from the antrum and corpus, following the protocol of the Operative Link for Gastritis Assessment (OLGA) and Sydney classifications for chronic gastritis. Biopsies will be examined at the Pathology laboratory of University College London Hospital and interpreted using the OLGA staging system as well as the Sydney system for the classification of gastritis (5-8).

The performance of the EndoFaster test for the diagnosis of Helicobacter pylori infection will be compared to the Clo test, the histologic diagnosis and the faecal antigen test. In particular, statistical analyses will consist of calculations of the performance indicators of the EndoFaster test, including ROC analysis for cut-off values that give the optimal sensitivity/specificity balance.

The principal goal of this clinical study is to establish the performance of the EndoFaster test in detecting the Helicobacter pylori infection rate in the study population. For this endpoint, we will calculate sensitivity (SE), specificity (SP), negative predictive value (NPV), positive predictive value (PPV) and AUC (area under ROC curve), collectively and individually for each 4 tests. ROC analysis can be used to estimate the best SE/SP balance for each single test. One of the aims is to establish the best cut-offs in order to give the EndoFaster test an optimal performance.

Additionally, clinically significant conditions (gastric atrophy, intestinal metaplasia, gastric cancer) will be recorded and the association rate with Helicobacter pylori infection will be studied (9,10).

The necessary preparations for the study execution at Homerton University Hospital NHS Foundation Trust will start immediately when the hospital has reached the agreement with NISO BIOMED. The study plan necessitates a review by the institutional review board (IRB, Ethical Committee) before permission to start.

We aim to obtain unbiased (i.e., 100% confirmed by the gold standard, i.e. faecal antigen test) estimate for the performance of EndoFaster test in detecting the Helicobacter pylori infection rate in patients on PPI treatment. This will include determining the optimal cut-offs that give the optimal SE/SP balance for detecting the study endpoint. Application of these cut-offs in clinical practice would lead to optimised performance of EndoFaster test.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Helicobacter pylori Gastritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with dyspepsia on PPI

One hundred patients on PPI will be enrolled among the patients with dyspepsia referred for gastroscopy at Homerton University Hospital. On the day of the endoscopic procedure the patients will bring a stool sample for the detection of faecal Helicobacter pylori antigen. Subsequently, a gastroscopy with multiple biopsies will be performed and during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out.

Gastroscopy

Intervention Type PROCEDURE

Gastroscopy with multiple biopsies will be performed in all patients enrolled

EndoFaster test

Intervention Type DEVICE

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

Clo test

Intervention Type OTHER

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

Faecal Helicobacter pylori antigen

Intervention Type OTHER

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

Patients with dyspepsia not on PPI

Fifty patients not on PPI will be enrolled among the patients with dyspepsia referred for gastroscopy at Homerton University Hospital. On the day of the endoscopic procedure the patients will bring a stool sample for the detection of faecal Helicobacter pylori antigen. Subsequently, a gastroscopy with multiple biopsies will be performed and during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out.

Gastroscopy

Intervention Type PROCEDURE

Gastroscopy with multiple biopsies will be performed in all patients enrolled

EndoFaster test

Intervention Type DEVICE

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

Clo test

Intervention Type OTHER

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

Faecal Helicobacter pylori antigen

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gastroscopy

Gastroscopy with multiple biopsies will be performed in all patients enrolled

Intervention Type PROCEDURE

EndoFaster test

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

Intervention Type DEVICE

Clo test

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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NISO Biomed EndoFaster test.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult females and males over 45 years of age with dyspeptic symptoms (epigastric pain, bloating and epigastric discomfort)

Exclusion Criteria

* Patients who require surgery or immediate follow-up treatment for major symptoms, including hematemesis, melena, acute epigastric pain
* Patients who previously underwent upper gastrointestinal surgery
* Patients with diabetes
* Pregnant women
* Subjects who refuse to participate or are unable to give consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Niso Biomed S.R.L.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cinzia Papadia, MD

Role: PRINCIPAL_INVESTIGATOR

Homerton University Hospital

Ray Shidrawi, MD

Role: STUDY_DIRECTOR

Homerton University Hospital

Marco Novelli, MD

Role: STUDY_CHAIR

University College, London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Homerton University Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cinzia Papadia, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

002

Identifier Type: -

Identifier Source: org_study_id