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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Live Combined Bifidobacterium

    Dietary supplement

    the Bifidobacterium genus supplement

  • Placebo

    Dietary supplement

    Placebo

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: receiving Bifidobacterium supplementsExperimental treatment 1 intervention
Group B: receiving placeboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
through study completion, an average of one year

Secondary outcomes

1

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.

Time frame
through study completion, an average of one year
2

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.

Time frame
through study completion, an average of one year
3

the thickness of Choroid

Choroidal hyperpermeability is one of the key mechanisms underlying the pathogenesis of central serous chorioretinopathy (CSC).

Time frame
through study completion, an average of one year
4

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.

Time frame
through study completion, an average of one year

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting310000, Hanzhou, ZhejiangChinaChina

Sponsors and contacts

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