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| Name | Class |
|---|---|
| Nutrarex Biotech Co., Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Subjects will take a capsule of containing microcrystalline cellulose per day for 35 days. |
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| Treatment group | Experimental | Subjects will take a capsule of containing Streptococcus thermophilus per day for 35 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Impression Cytology Change from Baseline | To assess the status of conjunctival goblet cells and epithelium. | on baseline and day36 |
| Ocular Surface Disease Index Score Change from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Pei-Cheng Lin | Chung Shan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jen-Ai Hospital | Taichung | 412 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18040913 | Background | 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. | |
| 6712760 | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D001248 | Asthenopia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days. |
|
A questionnaire is used to assess the health status on ocular surface, with higher scores indicating more severe status.
| on baseline and day36 |
| Intraocular Pressure Change from Baseline | To determine the effects of intervention on intraocular pressure. | on baseline and day36 |
| 1203224 | 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. |
| 25050925 | 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. |
| 10235562 | 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. |
| 18453777 | Background | Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097. |
| 28612893 | 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. |
| D019602 |
| Food and Beverages |