About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Live Combined Bifidobacterium
Dietary supplementthe Bifidobacterium genus supplement
Placebo
Dietary supplementPlacebo
Treatment groups
Trial outcomes
Primary outcomes
Best Corrected Visual Acuity
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.
Secondary outcomes
Central Retinal Thickness (CRT)
Central Retinal Thickness is typically assessed using imaging techniques such as optical coherence tomography (OCT), which provides detailed cross-sectional images of the retina, allowing for accurate measurement of its thickness.
the thickness of Subretinal Fluid (SRF)
Subretinal fluid can cause vision distortion and may require medical intervention to address the underlying condition and reduce fluid accumulation.
the thickness of Choroid
Choroidal hyperpermeability is one of the key mechanisms underlying the pathogenesis of central serous chorioretinopathy (CSC).
Choroidal Vascular Index (CVI)
This is a ratio or index that quantifies the proportion of the choroid occupied by blood vessels compared to the total choroidal area. It provides a measure of the relative density of the choroidal vasculature.
Locations
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Sponsors and contacts
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