NCT04294823

Sensitivity and Specificity of the Modified Helicobacter Test INFAI

Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal With Urea Breath Test in Helicobacter Pylori Positive and Negative Patients With Dyspepsia and GERD Taking Proton Pump Inhibitors

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: International Pharmaceutical Consultancy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to confirm the sensitivity of the C\^13-UBT using the new test meal for H. Pylori in patients with dyspepsia and GERD taking PPI Secondary objectives : to compare the sensitivity and specificity of the C\^13-UBT using the new test meal and standard test meal for H.Pylori in patients with dyspepsia and GERD taking PPI. to complete the results of the Helicbacter test INFAI using new test meal for H.Pylori in patients with dyspepsia and GERD taking PPI with : * Histology score for H.Pylori in antrum an corpus using the updated Sydney System * Sex, * Age, * Body Mass Index (BMI)

Detailed description

Helicobacter pylori (H. pylori) infection can be diagnosed by invasive (i.e., endoscopy and biopsy) and non-invasive techniques . The most accurate non-invasive tests for diagnosing active H. pylori are the 13C-urea breath test and the stool antigen test3 Several guidelines for the management of dyspeptic patients in primary care settings recommend the use of non-invasive tests for H. pylori in the initial management of dyspeptic patients (test and treat strategy)3 . This strategy has been tested in a number of clinical settings and has been shown to be effective from both a clinical and a cost perspective The urea breath test (UBT) and the stool antigen test are very sensitive and specific except in patients taking proton pump inhibitors (PPI) 678 In patients taking PPI, a positive test remains reliable for the detection of H. pylori but the number of false negative tests rises dramatically reducing the sensitivity of these tests. PPI are widely available and are over-thecounter agents in some countries (e.g. USA, Sweden). Clinicians are frequently confronted with making a diagnosis of H. pylori infection in patients who may knowingly or unknowingly be taking PPI. Currently available breath and stool tests are reliable 12 - 14 days after discontinuation of the PPI. This results in the cost and inconvenience of another visit and the possibility of symptoms in some patients when the PPI is withdrawn. Although the exact mechanism by which acid inhibition causes a false negative reaction is unclear, some studies have suggested that acidification of the stomach may reverse the abnormality Results have been inconsistent, however, and how to acidify the stomach and to what extent this should be done is unclear. Standardised test meals are routinely administered with the breath test substrate. The aim of this study is to assess the sensitivity and specificity of the 13C-urea breath test administered with the new test meal in patients with dyspepsia and GERD taking PPI.

Conditions

• Dyspepsia
• GERD

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Helicobacter Pylori Diagnostic	Helicobacter Test INFAI with standard test Meal (1g citric acid as test meal and 75 mg C\^13 urea) \+ The C\^13 UBT with the new test (REFEX). All patients will take Nexium mups (40 mg) orally once daily 30 min before breakfast from day 1 to 28.
DEVICE	Vital signs measurments	No description;
DIAGNOSTIC_TEST	endoscopy	Upper endoscopy where 6 biopsy samples will be obtained . Two biopsies will be taken from antrum and corpus for histology. The biopsies will be stained with Haematoxylin \& Eosin and Giemsa stains, and gastritis wilt be scored using the Updated Sydney System 12,13 Two biopsies will be taken from antrum and corpus for rapid urease test (RUT) and two biopsies will be taken from antrum and corpus for culture. All biopsy samples will be analysed in the local laboratory of the centre.
DRUG	Nexium Pill	patients will take Nexium mups 40 mg orally once daily, 30 min before breakfast Nexium mups 40 mg will be discontinued after Day 28.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-01-01
• Completion: 2021-02-01
• First posted: 2020-03-04
• Last updated: 2021-09-10

Locations

1 site across 1 country: France