ClinicalTrials.gg
RecruitingNCT06527326Updated May 27, 2026

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

An interventional study of Live Combined Bifidobacterium and Placebo in Central Serous Chorioretinopathy, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Sex
All
01

Study summary

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.

02

Conditions studied

  • Central Serous Chorioretinopathy

Keywords

  • central serous chorioretinopathy
  • Bifidobacterium genus
  • the gut dysbiosis
03

In context

Central Serous Chorioretinopathy

84 studies on the registry are indexed under Central Serous Chorioretinopathy; 14 are open to participants now.

This study's planned enrollment of 400 is above the median of 35 across 60 interventional studies indexed under Central Serous Chorioretinopathy.

Browse Central Serous Chorioretinopathy studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , and able to commit to follow-up

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    receiving Bifidobacterium supplements

    Dietary Supplement: Live Combined Bifidobacterium

  • Placebo comparator
    receiving placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementLive Combined Bifidobacterium

    the Bifidobacterium genus supplement

  • Dietary supplementPlacebo

    Placebo

06

What researchers measure

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

  5. 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.

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06527326
Responsible party
Sponsor
First posted
Jul 30, 2024
Start date
May 27, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
May 27, 2026

Study contacts

Weixin Zheng, master
Contact
22318933@zju.edu.cn
+86 18888918935
Panpan Ye, doctor
Contact
yepanpan@zju.edu.cn
+86 13806506267
Panpan Ye, doctor
principal investigator · 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion