the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Live Combined Bifidobacterium, Placebo.
- Who it may be relevant to
- Registry conditions: Central Serous Chorioretinopathy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Dietary supplement Live Combined Bifidobacterium
the Bifidobacterium genus supplement - Dietary supplement Placebo
Placebo
Primary outcome measures
- Best Corrected Visual Acuity [Time frame: through study completion, an average of one year]
Secondary outcome measures (5)
- Central Retinal Thickness (CRT) [Time frame: through study completion, an average of one year]
- the thickness of Subretinal Fluid (SRF) [Time frame: through study completion, an average of one year]
- the thickness of Choroid [Time frame: through study completion, an average of one year]
- Choroidal Vascular Index (CVI) [Time frame: through study completion, an average of one year]
- Choroidal Vascular Volume (CVV) [Time frame: through study completion, an average of one year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
China · 1 center
- 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hanzhou
Identifiers
NCT: NCT06527326 · 2024-0611