UBT as a Diagnostic Tool for HP Prevalance

NCT02570776 | Unknown

• 1 other identifier: PK-13-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Dyspepsia

Keywords

Helicobacter pylori; UBT; Sensitivity; specificity; prevalence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sensivity & specificity of Heliprobe (C14 UBT system) in local population

  1 day

Study Arms (1)

observation

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Liver & GI Diseases, Pakistan: lead
• Abbott: collaborator

Study Sites (1)

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

Karachi, Sindh, 0042, Pakistan

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Hypersensitivity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Zahid Azam, FCPS, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Medicine & Gastroenterology

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: October 7, 2015
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

PA (1)