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

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

Treatments tested in this trial

  • Live Combined Bifidobacterium
  • Placebo

Treatment groups

400 Participants
are divided into 2 treatment groups

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