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

NCT02123771 | Unknown

• 1 other identifier: 2011/00113
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Focus of Study : HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Helicobactor Pylori Infection

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 100 patients seen in Gastro clinic will be recruited for this study. Patient should 21 years and above and agreeable for study. Patient should not have been treated for H. pylori prior to stool collection.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Nuhs Umc/Udc

Singapore, Singapore, Singapore

RECRUITING

Related 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.

  PMID: 20347814 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples(solid/semi-solid) between 1-5 g will be collected and tested using ELISA for the presence of the H. pylori GGT antigen using monoclonal antibodies against GGT.

Study Officials

• Lee Guan Lim

  NUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Guan Lim

CONTACT

67795555

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Yeoh Khay Guan

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

SG (1)