NCT02123771

Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The investigators hypothesis: Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.

Detailed description

Subjects will be requested to provide 1-5g of their solid/semi-solid stool sample, to be collected within 24 hours prior to their scheduled visit for urea breath test. Patients should not have been treated for H. pylori prior to stool collection. Stool samples will be tested using ELISA for the presence of the H. pylori GGT antigen using monoclonal antibodies against GGT. Stool samples will also be tested for the presence of H. pylori DNA using PCR and Western blot analysis respectively. Presence of the GGT antigen in stool will be compared between H. pylori-positive and H. pylori-negative patients. Rapid urease test results will be used as the gold standard of H. pylori diagnosis. The sensitivity and specificity of the stool antigen test will be established.

Conditions

• HELICOBACTER PYLORI INFECTIONS

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-03-01
• First posted: 2014-04-28
• Last updated: 2014-04-28

Locations

1 site across 1 country: Singapore