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

• Conditions: HELICOBACTER PYLORI INFECTIONS

• Registration Number: NCT02123771
• Lead Sponsor: National University Hospital, Singapore

Brief 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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-25
• Last Update Submitted: 2014-04-25
• Study First Posted: 2014-04-28
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• The subject is greater than 21 years of age.
• The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
• The subject must be willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria

• Subjects who have been taking antibiotics over the past 1 month will be excluded from study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stool anti-GGT for the diagnosis of Helicobactor Pylori Infection	1 month after stool samples collected	1-5g of stool samples will also be collected from patients recruited to this study, in a preliminary investigation to determine the sensitivity and specificity of a stool H.pylori antigen test.; Rapid urese test is the gold standard.

Trial Locations

Locations (1)

Nuhs Umc/Udc; 🇸🇬 Singapore, Singapore