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NCT07148271

Effect of a Dietary Supplement on Gut Microbiota and Ocular Surface Outcomes in Dry Eye Disease

Sponsor: Varol TUNALI

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective Study Evaluating the Effects of a Dietary Supplement Product on Gut Microbiota and Ocular Surface Parameters in Patients With Dry Eye Disease

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-10-01

Completion Date

2026-03-15

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Dry Eye Meibomian Gland Dysfunction (Disorder)Dry Eye Disease (DED)Dry Eye Disease, Meibomian Gland Disease

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement Product

Participants will receive a dietary supplement product administered orally once daily for 8 weeks. The supplement is provided in sachet form and taken with water. The intervention is designed to modulate gut microbiota composition and diversity, with the potential to influence ocular surface outcomes in patients with dry eye disease. The regimen will be self-administered at home, with adherence monitored at study visits. Stool samples will be collected at baseline and week 8 for metagenomic sequencing, and ocular surface parameters will be assessed at the same time points. Safety will be evaluated by monitoring for adverse events throughout the intervention period.

Inclusion Criteria: 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. Exclusion Criteria: 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.

Locations (1)

Medipol University

Istanbul, Turkey (Türkiye)