HELICOBACTER PYLORI INFECTIONSNCT02123771
Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections
An observational study of HELICOBACTER PYLORI INFECTIONS, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The investigators hypothesis: Presence of anti-GGT (antibody against GGT) indicates H. pylori infection. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- May 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects who have been taking antibiotics over the past 1 month will be excluded from study.
Trial locations and contacts
1 site in 1 country.
Lee Guan Lim contact
Singapore1 site, 1 recruiting
- Recruiting
Nuhs Umc/Udc
Singapore, Singapore
Lee Guan Lim, 67795555
Lee Guan Lim
About this study
The investigators hypothesis:
Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.
Read the 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.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Focus of Study : HELICOBACTER PYLORI INFECTIONS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after stool samples collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gastroenterology & Hepatology, National University Hospital, Singapore
- Investigators
- Lee Guan Lim, Principal investigator, NUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123771
- Sponsor's protocol ID
- 2011/00113
- Status last verified
- Apr 2014
- First submitted
- 24 Apr 2014
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20347814
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections
- ClinicalTrials.gov ID
- NCT02123771
- Acronym / sponsor ID
- 2011/00113
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Focus of Study : HELICOBACTER PYLORI INFECTIONS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who have been taking antibiotics over the past 1 month will be excluded from study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stool anti-GGT for the diagnosis of Helicobactor Pylori Infection
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
- Background: PubMed 20347814Gong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Guan Lim contact
Lee Guan Lim principal investigator
NUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HELICOBACTER PYLORI INFECTIONS, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Guan Lim (67795555), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool anti-GGT for the diagnosis of Helicobactor Pylori Infection (time frame: 1 month after stool samples collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.