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

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

Detailed Description
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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.

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

Conditions
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HELICOBACTER PYLORI INFECTIONS

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Helicobactor Pylori Infection<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool anti-GGT for the diagnosis of Helicobactor Pylori Infection | 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. | 1 month after stool samples collected | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Focus of Study : HELICOBACTER PYLORI INFECTIONS