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

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.

Study Overview

• Status: Recruiting
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Live Combined Bifidobacterium

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weixin Zheng, master; Phone Number: +86 18888918935; Email: 22318933@zju.edu.cn
• Study Contact Backup: Name: Panpan Ye, doctor; Phone Number: +86 13806506267; Email: yepanpan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310000
      • Recruiting
      • 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Panpan Ye, doctor; Phone Number: +86 13806506267; Email: yepanpan@zju.edu.cn
      • Contact: Weixin Zheng, master; Phone Number: +86 18888918935; Email: 22318922@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: receiving Bifidobacterium supplements	Dietary supplement: Live Combined Bifidobacterium; the Bifidobacterium genus supplement
Placebo Comparator: receiving placebo	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Panpan Ye, doctor, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Estimated): May 27, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: central serous chorioretinopathy; Bifidobacterium genus; the gut dysbiosis
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: 2024-0611

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No