Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration
NCT ID: NCT05604989
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
45 participants
INTERVENTIONAL
2023-01-01
2024-11-30
Brief Summary
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The investigators recruit the neovascular AMD patients and control patients.
1. 15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement
2. 15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement
3. 15 control patients and no oral probiotics supplement
The investigators will collect stool, blood, and saliva sample at the baseline and 6 months, and analyze the oral and intestinal microbiome changes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement
Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis.
Oral probiotics (The Perfect Probiotics®) supplement will be given to the participants for 6 months.
Probiotic Combination Cap/Tab
The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus \& Bifidobacterium lactis.
intravitreal Anti-VEGF injection
Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.
neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement
Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis.
No Oral probiotics (The Perfect Probiotics®) supplement in this group.
intravitreal Anti-VEGF injection
Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.
Control patients, no oral probiotics supplement
Healthy, no retinal disease patients will be allocated. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis.
No Oral probiotics (The Perfect Probiotics®) supplement in this group.
No interventions assigned to this group
Interventions
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Probiotic Combination Cap/Tab
The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus \& Bifidobacterium lactis.
intravitreal Anti-VEGF injection
Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed as neovascular AMD (experimental \& sham group)
* Normal patients (control group)
Exclusion Criteria
* Past surgical history involving intestinal diseases
* Previous oral antibiotic treatment before 1 week at the baseline enroll
* Previous oral probiotics supplement
* Previous ophthalmic retinal diseases except neovascular AMD
40 Years
ALL
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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KWANGSIC JOO
Director, Deparment of Ophthalmology, Principal Investigator, Clinical Professor
Principal Investigators
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Kwangsic Joo, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Countries
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Other Identifiers
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AMDMICROBIOME
Identifier Type: -
Identifier Source: org_study_id
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