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Investigation of association between glaucoma and H. pylori infection by evaluating presence of Helicobacter pylori infection with C14 urea breath test

Investigation of association between glaucoma and H. pylori infection by evaluating presence of Helicobacter pylori infection with C14 urea breath test

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613001022752
Enrollment
70
Registered
2013-09-13
Start date
2011-08-11
Completion date
2012-07-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: To investigate the association between glaucoma and H. pylori infection by testing for the presence of H. pylori infection in patients with glaucoma using the 14C urea breath test. Methods: A comparison was made regarding H. pylori positivity using 14C urea breath testing (UBT) between a group of patients with primary open-angle glaucoma and a control group with normal intraocular pressure and no finding of glaucomatous optic disc. Results: The 14C urea breath test was positive in 18 (51.42%) out of 35 patients in the glaucoma group and in 15 (42.85%) out of 35 patients in the control group. The positivity rates were similar between the glaucoma and control groups and there was no significant difference between the groups (p>0.05). Conclusion: According to the 14C urea breath test, there is no association between primary open-angle glaucoma and H. pylori.

Interventions

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 (Hel

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

Sponsors

Medical Faculty of the Mustafa Kemal University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
28 Years to 80 Years
Healthy volunteers
No

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

Exclusion criteria

Patients who had previously undergone gastric surgery or those who had received treatment for H. pylori eradication were excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026