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

NCT06527326 | Recruiting

• 1 other identifier: 2024-0611
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Serous Chorioretinopathy

Keywords

central serous chorioretinopathy; Bifidobacterium genus; the gut dysbiosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Central Retinal Thickness (CRT)

  through study completion, an average of one year

• the thickness of Subretinal Fluid (SRF)

  through study completion, an average of one year

• the thickness of Choroid

  through study completion, an average of one year

• Choroidal Vascular Index (CVI)

  through study completion, an average of one year

• Choroidal Vascular Volume (CVV)

  through study completion, an average of one year

Study Arms (2)

receiving Bifidobacterium supplements

EXPERIMENTAL

Dietary Supplement: Live Combined Bifidobacterium

receiving placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Live Combined Bifidobacterium DIETARY_SUPPLEMENT

the Bifidobacterium genus supplement

receiving Bifidobacterium supplements

Placebo DIETARY_SUPPLEMENT

Placebo

receiving placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hanzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Panpan Ye, doctor

  2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weixin Zheng, master

CONTACT

+86 18888918935; 22318933@zju.edu.cn

Panpan Ye, doctor

CONTACT

+86 13806506267; yepanpan@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: May 27, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (1)