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 - A Pilot Study
Overview
- Phase
- Phase 3
- Intervention
- Probiotic Combination Cap/Tab
- Conditions
- Neovascular Age-related Macular Degeneration
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
- 15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement
- 15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement
- 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.
Investigators
KWANGSIC JOO
Director, Deparment of Ophthalmology, Principal Investigator, Clinical Professor
Seoul National University Bundang Hospital
Eligibility Criteria
Inclusion Criteria
- •Normal BMI patients
- •Diagnosed as neovascular AMD (experimental \& sham group)
- •Normal patients (control group)
Exclusion Criteria
- •Obese (BMI \> 30)
- •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
Arms & Interventions
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.
Intervention: Probiotic Combination Cap/Tab
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.
Intervention: intravitreal Anti-VEGF injection
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.
Intervention: intravitreal Anti-VEGF injection
Outcomes
Primary Outcomes
Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
Time Frame: 6 months after enrollment
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.
Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients
Time Frame: 6 months after enrollment
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.
Secondary Outcomes
- Visual acuity changes after oral probiotics supplement(6 months after enrollment)