Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02570776
Status:
UNKNOWN
Last Update Posted:
2015-10-07
First Post:
2014-05-07
Brief Title:
UBT as a Diagnostic Tool for HP Prevalance
Sponsor:
National Institute of Liver GI Diseases Pakistan
Organization:
National Institute of Liver GI Diseases Pakistan
Study Overview
Official Title:
Prevalence of Helicobacter Pylori Infection in Dyspeptic Adults and Validation of C14 Urea Breath Test UBT as a Diagnostic Tool for Helicobacter Pylori Infection in Pakistani Population
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of H pylori infection in Pakistan is unknown and investigators want to assess it in dyspeptic patients utilizing UBT At the same time investigators want to validate UBT sensitivity and specificity in Pakistani patients
Detailed Description:
The non-invasive methods for the diagnosis of Hp are the Urea Breath Test UBT and serological tests The serological tests includes ELISA test in serum for Hp antibody and in stool for Hp antigen Serum ELISA Hp antibody is not sensitive for showing active infection and the titres do not decrease even after successful eradication Serology test cannot be used for those who have previously been treated for Hp as the decline in titre of Hp antibodies is too slow to be of practical use The stool Hp antigen detection test is more sensitive and specific as it detects bacterial antigens which will only be positive in the presence of Hp However it is cumbersome to collect stool and laboratory services are required The C14 Urea Breath Test UBT is an office based test with sensitivity and specificity comparable to that of the stool antigen test The diagnostic validity of these tests depends on the prevalence of H pylori infection A higher prevalence would be associated with higher sensitivity and lower specificity The safety profile of the urea breath test is very favourable and no major side effects are associated with it The aims of this study are to estimate H pylori prevalence in Pakistan among the adult dyspeptic population and to validate the sensitivity and specificity UBT in our population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None