Investigating the link between gut bacteria and central serous chorioretinopathy
the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
This study is testing if the bacteria in our gut are connected to central serous chorioretinopathy and whether taking Bifidobacterium supplements can help improve vision and gut health in people with this eye condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hanzhou, Zhejiang) |
| Trial ID | NCT06527326 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the potential association between gut microbiota and central serous chorioretinopathy (CSC) by comparing fecal samples from CSC patients and healthy individuals. Researchers will utilize whole-metagenome shotgun sequencing to analyze gut microbiota compositions and identify significant differences. Additionally, participants diagnosed with acute CSC will be randomly assigned to receive either Bifidobacterium supplements or a placebo for at least one month, followed by assessments of their visual acuity and gastrointestinal health. The goal is to determine if gut dysbiosis is linked to CSC and if supplementation can improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of acute central serous chorioretinopathy and specific visual acuity criteria.
Not a fit: Patients with significant systemic diseases or severe visual impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into new treatment options for patients with central serous chorioretinopathy.
How similar studies have performed: While the association between gut microbiota and various conditions has been explored, this specific investigation into CSC is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hanzhou, Zhejiang
- 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hanzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Panpan Ye, doctor — 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
- Study coordinator: Weixin Zheng, master
- Email: 22318933@zju.edu.cn
- Phone: +86 18888918935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.