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A pilot study for Associations between the oral and intestinal microbiome and neovascular age-related macular degeneration and the investigation on the effect of oral probiotics as a treatment
The investigators recruit the neovascular AMD patients and control patients.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement | Experimental | 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. |
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| neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement | Sham Comparator | 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. |
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| Control patients, no oral probiotics supplement | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Combination Cap/Tab | Drug | The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus & Bifidobacterium lactis. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral microbiome changes after oral probiotics supplement in neovascular AMD patients | The investigators will analyze the oral microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups. Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months. | 6 months after enrollment |
| Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients | The investigators will analyze the intestinal microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups. Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months. | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity changes after oral probiotics supplement | If possible, visual acuity difference between experimental and sham group (oral probiotics vs. no oral probiotics) in the neovascular AMD patients. Visual acuity will be measured by the ETDRS eye chart (scale : letters). | 6 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwangsic Joo, MD PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
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| intravitreal Anti-VEGF injection | Drug | Intravitreal anti-VEGF injection treatment in the neovascular AMD patients. |
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