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

Not Applicable

Recruiting

• Conditions: Central Serous Chorioretinopathy
• Interventions: Dietary Supplement: Live Combined Bifidobacterium; Dietary Supplement: Placebo

• Registration Number: NCT06527326
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-27
• Status Verified: 2024-07
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
receiving Bifidobacterium supplements	Live Combined Bifidobacterium	-
receiving placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	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.

Secondary Outcome Measures

Name	Time	Method
Central Retinal Thickness (CRT)	through study completion, an average of one year	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)	through study completion, an average of one year	Subretinal fluid can cause vision distortion and may require medical intervention to address the underlying condition and reduce fluid accumulation.
Choroidal Vascular Index (CVI)	through study completion, an average of one year	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.
Choroidal Vascular Volume (CVV)	through study completion, an average of one year	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.
the thickness of Choroid	through study completion, an average of one year	Choroidal hyperpermeability is one of the key mechanisms underlying the pathogenesis of central serous chorioretinopathy (CSC).

Trial Locations

Locations (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hanzhou, Zhejiang, China