Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Chung Shan Medical University

Status: Completed

Conditions: Dry Eye

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05906381

202300014B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 20 and 65 years
• with Schirmer's test results less than 10 mm or Ocular Surface Disease Index more than 25

Exclusion criteria

• evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.
• diabetes
• hypertension
• or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Subjects will take a capsule of containing microcrystalline cellulose per day for 35 days.

Treatment:

Dietary Supplement: Placebo

Treatment group

Experimental group

Description:

Subjects will take a capsule of containing Streptococcus thermophilus per day for 35 days.

Treatment:

Dietary Supplement: Probiotics