Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001022752
Ethics application status
Approved
Date submitted
9/09/2013
Date registered
13/09/2013
Date last updated
13/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of association between glaucoma and H. pylori infection by evaluating presence of Helicobacter pylori infection with C14 urea breath test
Scientific title
Investigation of association between glaucoma and H. pylori infection by evaluating presence of Helicobacter pylori infection with C14 urea breath test
Secondary ID [1] 283176 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
glaucoma 290037 0
Helicobacter pylori 290038 0
Condition category
Condition code
Eye 290414 290414 0 0
Diseases / disorders of the eye
Infection 290441 290441 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
until the test result
Target follow-up type
Weeks
Description of intervention(s) / exposure
The 14C UBT is a non-invasive method with remarkable reliability. The 14C UBT used method for detecting H. pylori infections.
1. To prevent contamination from urease-producing resident flora in the mouth, patients brushed their teeth before the test. After overnight fasting (at least 4 hours), the patients swallowed 37 kBq (1 micro Ci) of an encapsulated form of C-14 (Helicap TM, Kibion, Uppsala, Sweden) with 50 mL of water. Breath samples were collected using a special dry cartridge system (Heliprobe BreathCard TM, Kibion, Uppsala, Sweden) at 10 minutes. Patients exhaled into the cartridge until the indicator membrane changed color from orange to yellow. The breath card was then inserted into a special Geiger-Muller counter (Heliprobe TM -analyser, Kibion, Stockholm, Sweden) and the activity counted for 250 seconds. The results were expressed both as counts per minute (CPM) and as grade (O: not infected, CPM < 25; 1: equivocal, CPM: 25–50; 2: infected, CPM > 50).
2. a) Completion of the test time is about 10 minutes
b) The test is undertaken in each participant on one occasion only.
3. Each participant was observed until the test result
Intervention code [1] 287904 0
Not applicable
Comparator / control treatment
1. The control group of patients has been selected from who have been made 14C UBT age-matched anemic patients.
2. The source: Department of Nucleer Medicine
time period: prospective
Control group
Active

Outcomes
Primary outcome [1] 290440 0
There was no significant difference between the study and control groups regarding rates of H. pylori infection and 14C UBT positivity (p=0.473).
The results were expressed both as counts per minute (CPM) and as grade (O: not infected, CPM < 25; 1: equivocal, CPM: 25–50; 2: infected, CPM > 50).
Timepoint [1] 290440 0
1 week after (Each participant was observed until the test result)
Secondary outcome [1] 304522 0
H. pylori was detected in 18 (52.9%) out of 35 patients with glaucoma vs. 15 (47.1%) out of 35 controls
The results were expressed both as counts per minute (CPM) and as grade (O: not infected, CPM < 25; 1: equivocal, CPM: 25–50; 2: infected, CPM > 50).
Timepoint [1] 304522 0
1 week after (Each participant was observed until the test result)

Eligibility
Key inclusion criteria
1. Patients with a diagnosis of primary open-angle glaucoma
2. The control group with normal IOP (<21 mmHg), normal perimetry or no finding of glaucomatous optic neuropathy, anemia
Minimum age
28 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had previously undergone gastric surgery or those who had received treatment for H. pylori eradication were excluded.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
11/08/2011
Date of last participant enrolment
Anticipated
Actual
15/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5400 0
Turkey
State/province [1] 5400 0
Hatay

Funding & Sponsors
Funding source category [1] 287927 0
University
Name [1] 287927 0
Medical Faculty of the Mustafa Kemal University
Country [1] 287927 0
Turkey
Primary sponsor type
University
Name
Medical Faculty of the Mustafa Kemal University
Address
From the Department of Ophthalmology, Medical Faculty of the Mustafa Kemal University , 31034 Hatay
Country
Turkey
Secondary sponsor category [1] 286653 0
None
Name [1] 286653 0
Address [1] 286653 0
Country [1] 286653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289858 0
Ethical Committee Gaziantep University Hospitals
Ethics committee address [1] 289858 0
Ethics committee country [1] 289858 0
Turkey
Date submitted for ethics approval [1] 289858 0
Approval date [1] 289858 0
Ethics approval number [1] 289858 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42758 0
Dr Esra Ayhan Tuzcu
Address 42758 0
From the Department of Ophthalmology, Medical Faculty of the Mustafa Kemal University, 31034, Hatay
Country 42758 0
Turkey
Phone 42758 0
+90,326,2291000
Fax 42758 0
Email 42758 0
[email protected]
Contact person for public queries
Name 42759 0
Esra Ayhan Tuzcu
Address 42759 0
From the Department of Ophthalmology, Medical Faculty of the Mustafa Kemal University, 31034, Hatay
Country 42759 0
Turkey
Phone 42759 0
+90,326,2291000
Fax 42759 0
Email 42759 0
[email protected]
Contact person for scientific queries
Name 42760 0
Esra Ayhan Tuzcu
Address 42760 0
From the Department of Ophthalmology, Medical Faculty of the Mustafa Kemal University, 31034, Hatay
Country 42760 0
Turkey
Phone 42760 0
+90,326,2291000
Fax 42760 0
Email 42760 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.