Clinical trial NCT06527326: the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
Official title: the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Serous Chorioretinopathy
Keywords: central serous chorioretinopathy
Bifidobacterium genus
the gut dysbiosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: through study completion, an average of one year
Secondary outcomes:
measure: Central Retinal Thickness (CRT)
timeFrame: through study completion, an average of one year
measure: the thickness of Subretinal Fluid (SRF)
timeFrame: through study completion, an average of one year
measure: the thickness of Choroid
timeFrame: through study completion, an average of one year
measure: Choroidal Vascular Index (CVI)
timeFrame: through study completion, an average of one year
measure: Choroidal Vascular Volume (CVV)
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Panpan Ye, doctor
role: PRINCIPAL_INVESTIGATOR
References: