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

HELICOBACTER PYLORI INFECTIONS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02123771
• Other study ID #: 2011/00113
• Status: Recruiting
• Phase: Phase 1
• First received: April 24, 2014
• Last updated: April 25, 2014
• Start date: May 2013

Study information

• Verified date: April 2014
• Source: National University Hospital, Singapore
• Contact: Lee Guan Lim
• Phone: 67795555
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial Summary

The investigators hypothesis:

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• HELICOBACTER PYLORI INFECTIONS
• Infection

Locations

Country	Name	City	State
Singapore	Nuhs Umc/Udc	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Gong M, Ling SS, Lui SY, Yeoh KG, Ho B. Helicobacter pylori gamma-glutamyl transpeptidase is a pathogenic factor in the development of peptic ulcer disease. Gastroenterology. 2010 Aug;139(2):564-73. doi: 10.1053/j.gastro.2010.03.050. Epub 2010 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No