An observational study in Dyspepsia, sponsored by National Institute of Liver & GI Diseases, Pakistan. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-07.
Sponsored by National Institute of Liver & GI Diseases, Pakistan · Observational
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
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
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's planned enrollment of 200 is close to the median of 192 across 56 observational studies indexed under Dyspepsia.
Browse Dyspepsia studies →This is the only study on the registry with National Institute of Liver & GI Diseases, Pakistan as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients getting routine upper GI Endoscopy are enrolled and as per routine histopathology samples are taken to assess Helicobacter pylori. This assessment will be done by two independent histopathologists \& later the results will be compared with C14 UBT taking histopathology as gold standard.
No Alarm symptoms of :
Exclusion Criteria:
Cohort of patients for Endoscopy \& they are assessed for Helicobacter pylori through the histopathology \& also throgh C14 C UBT.
Prevalence of H pylori infection in Pakistani polulation
Prevalence of H pylori will be assessed by UBT \& confirmed with histopathology as gold standard \& sensitivity \& specificity will be calculated.
Time frame: 1 day
Sensivity & specificity of Heliprobe (C14 UBT system) in local population
Sensitivity \& specificity will be measured by number of subjects positive based on ROC
Time frame: 1 day
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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