UBT as a Diagnostic Tool for HP Prevalance

Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02570776
• Other study ID #: PK-13-01
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2014
• Last updated: October 5, 2015
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: National Institute of Liver & GI Diseases, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects with dyspeptic symptoms (B1 Criteria of FD)

• Subject who has not been treated for H pylori eradication in the past

• Age above 18 years

• No Alarm symptoms of :

• Gastrointestinal Bleeding

• Anemia

• Early satiety

• Unexplained weight loss

• Progressive dysphagia

• Odynophagia

• Recurrent vomiting

• Family history of GI malignancy

• Previous GI malignancy

Exclusion Criteria:

• Pregnant females

• Use of NSAIDs

• Use of anti- secretory agent (H2 blockers) and proton pump inhibitors in previous 4 weeks

• Use of anti- microbial agents (Clarithromycin, Metronidazole, Amoxacillin, quinalones) or bismuth in last 4 weeks

• .Gastric and/or duodenal erosions or ulcers, polyps or malignancy if noted on endoscopy will be excluded.

• Patients with predominant symptoms or gastro esophageal reflux disease (GERD) or Endoscopic evidence of esophagitis.

• Patients with abnormal upper abdominal ultrasound.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspepsia

Locations

Country	Name	City	State
Pakistan	National Institute of Liver & GI Diseases, Dow University of Health Sciences	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Liver & GI Diseases, Pakistan	Abbott

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	No
Secondary	Sensivity & specificity of Heliprobe (C14 UBT system) in local population	Sensitivity & specificity will be measured by number of subjects positive based on ROC	1 day	No