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The outcome of dry eye parameters using oral probiotic supplement: a prospective, randomized study

The outcome of dry eye parameters using oral probiotic supplement: a prospective, randomized study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260527004
Enrollment
52
Registered
2026-05-27
Start date
2025-12-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate dry eyes patients dry eye disease, Ocular Surface Disease Index, ocular surface staining, tear break up time, probiotic

Interventions

Oral probiotic containing 3 specific species (Lactobacillus paracasei MSMC 39-1, Lactobacillus reuteri TF-314, Bifidobacterium animalis TA-1) in capsule form is taken 1 capsule daily in the morning fo
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Oral probiotic,Maltodextrin

Sponsors

Faculty of medicine, Srinakharinwirot university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: A patient with T-OSDI score of more than 13 points with at least one of the following sign 1. ocular surface staining defines as cornea staining more than 5 spots OR conjunctival staining more than 9 spots OR eyelid margin staining length more than 2 mm and width more than 25% 2. Tear break up time less than 10 seconds

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating 2. underlying ocular (lacrimal or corneal disease) or systemic disease (autoimmune or neurologic disease) 3. previous ocular surgery or refractive surgery within 1 year 4. contact lens use (within 1 yr) 5. current topical medication; steroid , secretagogues, cyclosporine 6. current systemic medication: steroid, vitamin A derivative, hormone replacement therapy, oral contraceptive pill,beta-blocker, psychiatric pill, antihistamine, sedative/sleeping pill, regular analgesic 7. previously or currently taking probiotic 8. allergic to probiotic 9. contraindicated for probiotic: immunocompromised, Hx of chemotherapy, structural heart disease 10. allergy to maltodextrin 11. history of antibiotic use (within 60 days)

Design outcomes

Primary

MeasureTime frame
Non- invasive tear break up time at 1 month after the end of the intervention Keratograph 5M

Secondary

MeasureTime frame
Ocular surface staining At 1 month after the end of the intervention Fluorescein staining,Lipid layer thickness/quality at 1 month after the end of the intervention Keratograph 5M,Conjunctival redness at 1 month after the end of the intervention Keratograph 5M ,Tear osmolarity at 1 month after the end of the intervention TearLab osmolarity test card ,Dry eyes symptoms at 1 month after the end of the intervention T-OSDI questionaire

Countries

Thailand

Contacts

Public ContactSumalee Boonyaleephan

Srinakharinwirot university

sumaleeb@g.swu.ac.th037 395085

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026