UBT as a Diagnostic Tool for HP Prevalance

NCT ID: NCT02570776

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-02-29

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

Conditions

Dyspepsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

observation

Cohort of patients for Endoscopy \& they are assessed for Helicobacter pylori through the histopathology \& also throgh C14 C UBT.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

National Institute of Liver & GI Diseases, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Dr. Zahid Azam

Professor Medicine & Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zahid Azam, FCPS, MSc

Role: PRINCIPAL_INVESTIGATOR

National Institute of Liver & GI Diseases, Dow University of Health Sciences

Locations

National Institute of Liver & GI Diseases, Dow University of Health Sciences

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Facility Contacts

Zahid Azam, FCPS, MSc

Role: primary

zahid.azam@duhs.edu.pk

+922199261462

Abdullah Khalid, MBBS; FCPS

Role: backup

abdullah.khalid@duhs.edu.pk

+922199261462

Other Identifiers

PK-13-01

Identifier Type: -

Identifier Source: org_study_id