Dry Eye Symptom Mitigation by Oral Intake of Probiotics

NCT05906381 | Completed DMC

• 1 other identifier: 202300014B0
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

probiotics; dry eye; eye sore; eye strain

Outcome Measures

Primary Outcomes (5)

• Change of Schirmer's Test Value from Baseline

  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.

  on baseline and day36

• Change of Tear Film Breakup Time from Baseline

  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.

  on baseline and day36

• Ocular Surface Index Change from Baseline

  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.

  on baseline and day36

• Tear Osmolality Change from Baseline

  Tear osmolality is used as a parameter of dry eye status.

  on baseline and day36

• Serum Biochemical Test

  To determine the effects of oral probiotics intake on the contents of hyaluronic acid, sialic acid, and glutathione in the serum.

  on baseline and day36

Secondary Outcomes (3)

• Ocular Surface Impression Cytology Change from Baseline

  on baseline and day36

• Ocular Surface Disease Index Score Change from Baseline

  on baseline and day36

• Intraocular Pressure Change from Baseline

  on baseline and day36

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Treatment group

EXPERIMENTAL

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

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

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

Treatment group

Placebo DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chung Shan Medical University: lead
• Nutrarex Biotech Co., Ltd.: collaborator

Study Sites (1)

Jen-Ai Hospital

Taichung, 412, Taiwan

Location

Related Publications (7)

• Herrero-Vanrell R, Peral A. [International Dry Eye Workshop (DEWS). Update of the disease]. Arch Soc Esp Oftalmol. 2007 Dec;82(12):733-4. doi: 10.4321/s0365-66912007001200002. No abstract available. Spanish.

  PMID: 18040913 BACKGROUND

• Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.

  PMID: 6712760 BACKGROUND

• Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975 Nov;59(11):667-9. doi: 10.1136/bjo.59.11.667.

  PMID: 1203224 BACKGROUND

• Brito-Zeron P, Ramos-Casals M; EULAR-SS task force group. Advances in the understanding and treatment of systemic complications in Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):520-7. doi: 10.1097/BOR.0000000000000096.

  PMID: 25050925 BACKGROUND

• Sullivan DA, Krenzer KL, Sullivan BD, Tolls DB, Toda I, Dana MR. Does androgen insufficiency cause lacrimal gland inflammation and aqueous tear deficiency? Invest Ophthalmol Vis Sci. 1999 May;40(6):1261-5.

  PMID: 10235562 BACKGROUND

• Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097.

  PMID: 18453777 BACKGROUND

• Chisari G, Chisari EM, Francaviglia A, Chisari CG. The mixture of bifidobacterium associated with fructo-oligosaccharides reduces the damage of the ocular surface. Clin Ter. 2017 May-Jun;168(3):e181-e185. doi: 10.7417/T.2017.2002.

  PMID: 28612893 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Asthenopia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Pei-Cheng Lin

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 15, 2023
• Study Start: May 13, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 26, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)