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

NCT07148271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-18

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    collaborator OTHER

  • Liv Hospital (Ulus)

    collaborator UNKNOWN

  • Varol TUNALI

    lead INDUSTRY

Principal Investigators

  • Varol TUNALI, Dr. · Celal Bayar University Faculty of Medicine Parasitology Department

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-12-20
Completion
2026-01-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148271 on ClinicalTrials.gov