NCT06527326 the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
| NCT ID | NCT06527326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Central Serous Chorioretinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-05-27 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Panpan Ye, doctor
PRINCIPAL INVESTIGATOR
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT06527326 clinical trial?
This trial is open to participants of all sexes, studying Central Serous Chorioretinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06527326 currently recruiting?
Yes, NCT06527326 is actively recruiting participants. Contact the research team at 22318933@zju.edu.cn for enrollment information.
Where is the NCT06527326 trial being conducted?
This trial is being conducted at Hanzhou, China.
Who is sponsoring the NCT06527326 clinical trial?
NCT06527326 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Panpan Ye, doctor at 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 400 participants.