Dry Eye Symptom Mitigation by Oral Intake of Probiotics

NCT ID: NCT05906381

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-13
• Study Completion Date: 2023-12-31

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.

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

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Treatment group

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

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotics

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutrarex Biotech Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Pei-Cheng Lin

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

Jen-Ai Hospital

Taichung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 18040913 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6712760 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1203224 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25050925 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10235562 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 18453777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28612893 (View on PubMed)

Other Identifiers

202300014B0

Identifier Type: -

Identifier Source: org_study_id