the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy

Zhejiang University

Status: Enrolling

Conditions: Central Serous Chorioretinopathy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Live Combined Bifidobacterium

Study type: Interventional

Funder types: Other

Identifiers

NCT06527326

2024-0611

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

receiving Bifidobacterium supplements

Experimental group

Treatment:

Dietary Supplement: Live Combined Bifidobacterium

receiving placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo