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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| receiving Bifidobacterium supplements | Experimental |
| |
| receiving placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Combined Bifidobacterium | Dietary Supplement | the Bifidobacterium genus supplement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weixin Zheng, master | Contact | +86 18888918935 | 22318933@zju.edu.cn | |
| Panpan Ye, doctor | Contact | +86 13806506267 | yepanpan@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Panpan Ye, doctor | 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Recruiting | Hanzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D056833 | Central Serous Chorioretinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Placebo | Dietary Supplement | Placebo |
|
| 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 |