Trials / Completed
CompletedNCT05906381
Dry Eye Symptom Mitigation by Oral Intake of Probiotics
A Clinical Trial of Dry Eye Symptom Mitigation by Oral Intake of Probiotics
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Chung Shan Medical University · Academic / Other
- Sex
- All
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates whether the oral intake of a probiotics capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 1 probiotics capsule per day for 35 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, tear osmolarity and serum biochemical test. After the 35 days are completed, the participants will be assessed again for the same parameters.
Detailed description
This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to control group or treatment group, and asked to orally intake 1 capsule of either placebo or probiotics per day. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear osmolarity, ocular surface impression cytology, ocular surface disease index (OSDI) and serum biochemical tests for quantification of hyaluronic acid, sialic acid, glutathione contents.The assessments are conducted at day1 for baseline and after the 35-day oral intake. The parameters are used to compare and evaluate whether the probiotics can relieve dry eye symptoms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotics | A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days. |
| DIETARY_SUPPLEMENT | Placebo | A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days. |
Timeline
- Start date
- 2023-05-13
- Primary completion
- 2023-08-31
- Completion
- 2023-12-31
- First posted
- 2023-06-15
- Last updated
- 2025-09-26
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05906381. Inclusion in this directory is not an endorsement.