Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04294823
Status:
WITHDRAWN
Last Update Posted:
2021-09-10
First Post:
2020-03-02
Brief Title:
Sensitivity and Specificity of the Modified Helicobacter Test INFAI
Sponsor:
International Pharmaceutical Consultancy
Organization:
International Pharmaceutical Consultancy
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative delays were too long
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study to confirm the sensitivity of the C13-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 C13-UBT using the new test meal and standard test meal for HPylori in patients with dyspepsia and GERD taking PPI
to complete the results of the Helicbacter test INFAI using new test meal for HPylori in patients with dyspepsia and GERD taking PPI with
Histology score for HPylori in antrum an corpus using the updated Sydney System
Sex
Age
Body Mass Index BMI
Secondary objectives to compare the sensitivity and specificity of the C13-UBT using the new test meal and standard test meal for HPylori in patients with dyspepsia and GERD taking PPI
to complete the results of the Helicbacter test INFAI using new test meal for HPylori in patients with dyspepsia and GERD taking PPI with
Histology score for HPylori 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 ie 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 strategy3 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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None