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NCT Number: NCT06527326

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

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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Key information

Conditions

Central Serous Chorioretinopathy Eye Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Live Combined Bifidobacterium

Dietary Supplement

the Bifidobacterium genus supplement

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Best Corrected Visual Acuity

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

    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.

Secondary outcomes

  1. Central Retinal Thickness (CRT)

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

    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.

  2. the thickness of Subretinal Fluid (SRF)

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

    Subretinal fluid can cause vision distortion and may require medical intervention to address the underlying condition and reduce fluid accumulation.

  3. the thickness of Choroid

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

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

  4. Choroidal Vascular Index (CVI)

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

    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.

  5. Choroidal Vascular Volume (CVV)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Panpan Ye, doctor

CONTACT

[email protected]

+86 13806506267

Weixin Zheng, master

CONTACT

[email protected]

+86 18888918935

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 30, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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