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

National University Health System (NUHS)

Status: Unknown

Conditions: HELICOBACTER PYLORI INFECTIONS

Study type: Observational

Funder types: Other

Identifiers

NCT02123771

2011/00113

Details and patient eligibility

About

The investigators hypothesis:

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Helicobactor Pylori Infection

Description:

Comparison on the presence/absence of GGT antigen in the stool will be compared between H. pylori-positive and H. pylori-negative subjects. Rapid urease test result from the respective patients will be used as the golden standard. Should the GGT antigen in stool samples show promise in distinguishing between H. pylori-infected and uninfected individuals, sensitivity and specificity of the stool antigen test can then be established.