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

NCT02126722 | Unknown

• 1 other identifier: 002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Infections

Keywords

Helicobacter pylori; Gastritis

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the EndoFaster test in H. pylori diagnosis

  Clinical specialist consultation will be performed and eligible patients will be enrolled and candidate to undergo a gastroscopy. 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. Performance indicators (sensitivity, specificity, positive predictive value, PPV, negative predictive value, NPV and their 95%CI) of the EndoFaster test will be calculated, using the STATA/SE software. The area under ROC (Receiver Operating Characteristics) called AUC, will be identified. These ROC curves can be used to identify the optimal sensitivity/specificity balance that gives each biomarker an optimal threshold for detection of each study endpoint. Significance of the difference between AUC values can be estimated using STATA's roccomb test with 95%CI.

  Six weeks

Study Arms (2)

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.

Procedure: Gastroscopy; Device: EndoFaster test; Other: Clo test; Other: Faecal 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.

Procedure: Gastroscopy; Device: EndoFaster test; Other: Clo test; Other: Faecal Helicobacter pylori antigen

Interventions

Gastroscopy PROCEDURE

Gastroscopy with multiple biopsies will be performed in all patients enrolled

Patients with dyspepsia not on PPI; Patients with dyspepsia on PPI

EndoFaster test DEVICE

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

Also known as: NISO Biomed EndoFaster test.

Patients with dyspepsia not on PPI; Patients with dyspepsia on PPI

Clo test OTHER

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

Patients with dyspepsia not on PPI; Patients with dyspepsia on PPI

Faecal Helicobacter pylori antigen 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; Patients with dyspepsia on PPI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Niso Biomed S.R.L.: lead

Study Sites (1)

Homerton University Hospital

London, E9 6SR, United Kingdom

Location

MeSH Terms

Conditions

Helicobacter Infections; Gastritis

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Cinzia Papadia, MD

  Homerton University Hospital

  PRINCIPAL INVESTIGATOR

• Ray Shidrawi, MD

  Homerton University Hospital

  STUDY DIRECTOR

• Marco Novelli, MD

  University College, London

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

GB (1)