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Clinical Trial Summary

The investigators hypothesis:

Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.


Clinical Trial 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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02123771
Study type Observational
Source National University Hospital, Singapore
Contact Lee Guan Lim
Phone 67795555
Status Recruiting
Phase Phase 1
Start date May 2013

See also
  Status Clinical Trial Phase
Recruiting NCT03419936 - Distribution of Helicobacter Pylori After Gastrectomy N/A
Recruiting NCT02047994 - Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality Phase 4