the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
To investigate the potential association between gut microbiota and central serous chorioretinopathy (CSC), clinical observations have indicated that patients with CSC frequently present with chronic gastrointestinal symptoms. This observation has led to the hypothesis that CSC may be associated with gut dysbiosis.
The genus Bifidobacterium is widely recognized as a beneficial component of the gut microbiota, and multiple well-established Bifidobacterium supplements are commercially available. To explore this potential association, fecal samples will be collected from both CSC patients and healthy controls. Whole-metagenome shotgun sequencing will be performed to compare gut microbial compositions between the two groups and to determine whether significant differences exist.
In addition, CSC patients will be randomly assigned to two groups. One group will receive Bifidobacterium supplementation for a minimum of one month, while the other group will receive a placebo. Clinical outcomes will then be evaluated to assess whether Bifidobacterium supplementation is associated with faster recovery and reduced relapse rates compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 60 years
- •Diagnosis of acute central serous chorioretinopathy (CSC) (affected eye: ① FFA and ICGA showing typical CSC manifestations, ② presence of subretinal fluid (SRF) at the macular fovea, ③ disease duration ≤ 6 months)
- •Best Corrected Visual Acuity (BCVA): 53 to 86 letters
- •Other: No significant systemic diseases, signed informed consent, and able to commit to follow-up
排除标准
- •Presence of significant systemic diseases
- •BCVA of 20/200 or worse
- •Presence of choroidal or retinal atrophy in the macular fovea of the affected eye
- •Presence of choroidal neovascularization (CNV), age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), diabetic retinopathy (DR), choroidal hemangioma, pigment epithelial detachment (PED), etc., in the affected eye
- •High myopia in the affected eye
研究组 & 干预措施
receiving Bifidobacterium supplements
干预措施: Live Combined Bifidobacterium (Dietary Supplement)
receiving placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: through study completion, an average of one year
BCVA is commonly assessed during eye exams to determine the effectiveness of vision correction and to evaluate the impact of eye conditions or diseases on vision.
次要结局
- Central Retinal Thickness (CRT)(through study completion, an average of one year)
- the thickness of Subretinal Fluid (SRF)(through study completion, an average of one year)
- Choroidal Vascular Index (CVI)(through study completion, an average of one year)
- Choroidal Vascular Volume (CVV)(through study completion, an average of one year)
- the thickness of Choroid(through study completion, an average of one year)