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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal BMI patients
- •Diagnosed as neovascular AMD (experimental & sham group)
- •Normal patients (control group)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Probiotic Combination Cap/Tab (Drug)
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.
干预措施: intravitreal Anti-VEGF injection (Drug)
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.
干预措施: intravitreal Anti-VEGF injection (Drug)
结局指标
主要结局
Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
时间窗: 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
时间窗: 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.
次要结局
- Visual acuity changes after oral probiotics supplement(6 months after enrollment)
研究者
KWANGSIC JOO
Director, Deparment of Ophthalmology, Principal Investigator, Clinical Professor
Seoul National University Bundang Hospital