the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
NCT Number: NCT06527326
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Central Serous Chorioretinopathy
Interventions: DIETARY_SUPPLEMENT: Live Combined Bifidobacterium|DIETARY_SUPPLEMENT: Placebo
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-27
Completion Date: 2026-07-01
Locations: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hanzhou, Zhejiang, 310000, China

Summary:
To investigate the potential association between gut microbiota and central serous chorioretinopathy (CSC), we have observed in our clinical practice that CSC patients often experience chronic gastrointestinal issues. This observation has led us to hypothesize that CSC may be associated with gut dysbiosis. The Bifidobacterium genus is widely recognized as a beneficial gut bacterium, and numerous well-established Bifidobacterium supplements are available on the market. To explore this possible connection, we will collect fecal samples from both CSC patients and healthy individuals. Using whole-metagenome shotgun sequencing, we will compare the gut microbiota compositions of the two groups to determine if significant differences exist. Additionally, we will randomly assign patients to two groups: one group will receive Bifidobacterium supplements for at least one month, while the other group will receive a placebo. We will then assess whether the group receiving the supplements experiences faster recovery and lower relapse rates compared to the placebo group.

Primary Outcome Measures: 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., through study completion, an average of one year
Secondary Outcome Measures: 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., through study completion, an average of one year|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., through study completion, an average of one year|the thickness of Choroid, Choroidal hyperpermeability is one of the key mechanisms underlying the pathogenesis of central serous chorioretinopathy (CSC)., through study completion, an average of one year|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., through study completion, an average of one year|Choroidal Vascular Volume (CVV), This measures the total volume of the choroidal blood vessels within a specific area of the choroid. It reflects the overall blood vessel density and the amount of blood flowing through the choroidal vasculature., through study completion, an average of one year