Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Sponsor

Chung Shan Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05906381

Collaborator

Nutrarex Biotech Co., Ltd. (Other)

Enrollment

Location

Arms

7.6

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Dietary Supplement: Probiotics Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

A Clinical Trial of Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Actual Study Start Date :

May 13, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Subjects will take a capsule of containing microcrystalline cellulose per day for 35 days.	Dietary Supplement: Placebo A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days.
Experimental: Treatment group Subjects will take a capsule of containing Streptococcus thermophilus per day for 35 days.	Dietary Supplement: Probiotics A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days.

Arm

Intervention/Treatment

Placebo Comparator: Control group

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

Dietary Supplement: Placebo

A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days.

Experimental: Treatment group

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

Dietary Supplement: Probiotics

A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days.

Outcome Measures

Primary Outcome Measures

Change of Schirmer's Test Value from Baseline [on baseline and day36]
The Schirmer's Test is used to assess tear secretion volume. The amounts of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement amount is regarded as a parameter of presence of dry eye disease.
Change of Tear Film Breakup Time from Baseline [on baseline and day36]
Tear Break-Up Time is a measurement to reflect tear quality and is expressed in seconds. The shorter the Tear Break-Up Time, the poorer the tear film stability and quality. Lower measurement outcome (less than 10 seconds) is regarded as a parameter of presence of dry eye disease.
Ocular Surface Index Change from Baseline [on baseline and day36]
Ocular Surface Index is assessed with fluorescein staining to reflect ocular surface damages. The staining scale ranges from 0 to 3, from milder to severe status, where grade 0 shows no staining, and grade 3 shows extensive staining.
Tear Osmolality Change from Baseline [on baseline and day36]
Tear osmolality is used as a parameter of dry eye status.
Serum Biochemical Test [on baseline and day36]
To determine the effects of oral probiotics intake on the contents of hyaluronic acid, sialic acid, and glutathione in the serum.

Secondary Outcome Measures

Ocular Surface Impression Cytology Change from Baseline [on baseline and day36]
To assess the status of conjunctival goblet cells and epithelium.
Ocular Surface Disease Index Score Change from Baseline [on baseline and day36]
A questionnaire is used to assess the health status on ocular surface, with higher scores indicating more severe status.
Intraocular Pressure Change from Baseline [on baseline and day36]
To determine the effects of intervention on intraocular pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)