A Prospective Study Evaluating the Effects of a Dietary Supplement Product on Gut Microbiota and Ocular Surface Parameters in Patients With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Schirmer Test Score
研究概览
简要总结
This prospective clinical study investigates whether a dietary supplement product can modulate the gut microbiota and improve ocular surface outcomes in patients with dry eye disease. Participants will be recruited from Istanbul Medipol University Hospital (Department of Ophthalmology) and Liv Hospitals (Vadi Istanbul and Ulus). Each participant will receive the dietary supplement product for 8 weeks. Gut microbiota analyses will be conducted at baseline and week 8. Ocular surface assessments including Schirmer test and invasive tear breakup time (TBUT) will be performed at baseline and week 8.
详细描述
Dry eye disease (DED) is a multifactorial ocular surface disorder characterized by chronic tear film instability, hyperosmolarity, and ocular surface inflammation. It represents one of the most common reasons for ophthalmology consultations worldwide and has a profound impact on patient quality of life. Conventional treatment approaches primarily target symptoms and tear film supplementation, but disease-modifying interventions remain limited.
Emerging evidence suggests that the gut microbiota exerts systemic immunomodulatory effects, influencing diseases beyond the gastrointestinal tract, including ocular conditions. Dysbiosis has been implicated in autoimmune, metabolic, and inflammatory disorders, and a growing body of literature indicates that the gut-eye axis may play a role in the pathogenesis of DED. Specific microbiota-derived metabolites, microbial antigens, and immune pathways are believed to modulate ocular surface inflammation and tear film stability. This provides a strong rationale for exploring microbiome-targeted interventions in DED.
This single-arm, prospective interventional trial investigates the impact of an 8-week course of a defined dietary supplement product on gut microbiota composition and diversity, alongside established ocular surface clinical endpoints. Participants will be recruited from Istanbul Medipol University Hospital (Department of Ophthalmology) and Liv Hospitals (Vadi Istanbul and Ulus). All enrolled patients will receive the dietary supplement once daily for the study duration.
Microbiome assessment: Stool samples will be collected at baseline and at week 8, with DNA extraction followed by metagenomic sequencing. Microbiota analysis will focus on alpha diversity (e.g., Shannon index) and taxonomic/functional profiling to detect shifts in microbial composition associated with the intervention.
Ophthalmological assessment: Clinical evaluations will be performed at baseline and at week 8, including the Schirmer test, invasive tear breakup time (TBUT), Ocular Surface Disease Index (OSDI), and Dry Eye Scoring System (DESS). These standardized measures provide quantitative and qualitative assessment of tear production, stability, and patient-reported symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years.
- •Clinical diagnosis of dry eye disease with clinically significant symptoms, defined as Ocular Surface Disease Index (OSDI) score ≥23 at screening and/or baseline.
- •Evidence of tear film instability consistent with dry eye disease, defined as fluorescein tear break-up time (TBUT) ≤10 seconds in at least one eye at screening and/or baseline.
- •Willing and able to provide written informed consent.
- •Willing to maintain habitual diet and lifestyle during the study period and to avoid initiating new microbiome-active products (e.g., probiotic/prebiotic/synbiotic supplements) during the intervention.
排除标准
- •Current restrictive dietary pattern likely to materially alter gut microbiota (e.g., ketogenic diet, elimination diets, prolonged fasting) or planned major dietary change during the study period.
- •Colonoscopy within the past 4 weeks.
- •Systemic antibiotic use within the past 4 weeks.
- •Use of probiotic, prebiotic, synbiotic, postbiotic, or fecal microbiota-related products within the past 4 weeks.
- •Active ocular infection or acute ocular inflammation requiring treatment escalation (e.g., acute blepharitis flare, active allergic conjunctivitis requiring escalation), at screening/baseline.
- •Sjögren syndrome or other active systemic autoimmune disease with clinically significant ocular involvement, in the investigator's judgment.
- •Ocular surgery (including refractive surgery) or significant ocular trauma within the past 6 months.
- •Contact lens wear within 30 days prior to baseline or planned contact lens use during the study.
- •Topical cyclosporine, lifitegrast, or topical ocular corticosteroid use within 8-12 weeks prior to baseline, or planned initiation during the study.
- •Punctal plug placement within the past 3 months or planned during the study.
- •Known hypersensitivity to any component of the study product.
- •Any other systemic or ocular condition that, in the investigator's judgment, could compromise participant safety or interfere with study outcomes.
研究组 & 干预措施
Intervention arm
干预措施: Dietary Supplement Product (Dietary Supplement)
结局指标
主要结局
Change in Schirmer Test Score
时间窗: From enrollment to the end of treatment at 8 weeks
Tear production will be assessed using the Schirmer Test without anesthesia at baseline and at week 8. Standardized Schirmer paper strips will be placed in the lower eyelid, and the length of strip wetting (measured in millimeters) will be recorded after 5 minutes. The Schirmer Test yields values ranging from 0 mm (no tear production) to approximately 35 mm (normal/high tear production) over 5 minutes. Higher values represent better tear production, while values \<10 mm/5 min are commonly associated with clinically significant dry eye disease. The primary endpoint is the mean change in Schirmer Test score from baseline to week 8.
Change in Schirmer Test Score
时间窗: Baseline to Week 8 (Treatment End) and Baseline to Week 16 (Follow-up)
Tear production will be assessed using the Schirmer Test without anesthesia at baseline and at week 8. Standardized Schirmer paper strips will be placed in the lower eyelid, and the length of strip wetting (measured in millimeters) will be recorded after 5 minutes. The Schirmer Test yields values ranging from 0 mm (no tear production) to approximately 35 mm (normal/high tear production) over 5 minutes. Higher values represent better tear production, while values \<10 mm/5 min are commonly associated with clinically significant dry eye disease. The primary endpoint is the mean change in Schirmer Test score from baseline to week 8 and from baseline to Week 16 (Follow-up).
次要结局
- Change in Dry Eye Scoring System (DESS)(From enrollment to the end of treatment at 8 weeks)
- Change in Tear Breakup Time (TBUT, invasive)(From enrollment to the end of treatment at 8 weeks)
- Change in Ocular Surface Disease Index (OSDI)(From enrollment to the end of treatment at 8 weeks)
- Change in gut microbiota diversity (Shannon index)(From enrollment to the end of treatment at 8 weeks)
- Change in Tear Breakup Time (TBUT, invasive)(Baseline to Week 8 (Treatment End) and Baseline to Week 16 (Follow-up))
- Change in Ocular Surface Disease Index (OSDI)(Baseline to Week 8 (Treatment End) and Baseline to Week 16 (Follow-up))
- Change in Dry Eye Questionnaire-5 (DEQ-5)(Baseline to Week 8 (Treatment End) and Baseline to Week 16 (Follow-up))
研究者
Varol TUNALI
Doctor
ENBIOSIS BIOTECHNOLOGIES