NCT04938908

Probiotic in Dry Eye Syndromes

Efficacy and Safety of Systemic and Ophthalmic Probiotic on Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate efficacy and safety of systemic and ophthalmic probiotic from bacterial lysate of Lactobacillus sakei on microbiota, immunological and clinical outcomes of patients with Dry Eye Syndrome.

Detailed description

The ocular surface is comprised of the cornea and its overlying tissue, the conjunctiva. The ocular surface is continuously exposed to the external environment and, therefore, to different microbial species. A resident ocular surface microbiota has been found in various studies. Although little is known so far, some elements of this microbiota and/or its metabolites could represent protective cofactosr in the pathogenesis of common ocular diseases. On the other hand, the gut microbiota is known to influence host homeostasis in distal tissues, such as brain (gut-barin axis), lungs (gut-lungs axis) and skin (gut-skin axis). However, little is known about distal effects of the gut microbiota on the ocular surface. In this study we sought to evaluate the efficacy and safety aspects of L.sakei as both ophtalmic probiotic lysate and oral live probiotic on Dry Eye Syndrome, using a factorial design, against placebo.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	Ophthalmic Probiotic	Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.
DRUG	Opthalmic Placebo	Placebo contains complete formulation of the active drug except for bacterial lysate of Lactobacillus sakei (i.e. HPMC, boric acid, sodium chloride, purified water)
DIETARY_SUPPLEMENT	Oral Probiotic Capsule	Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient
DIETARY_SUPPLEMENT	Oral Placebo Capsule	Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-06-30
• Completion: 2022-07-30
• First posted: 2021-06-25
• Last updated: 2023-03-27

Locations

1 site across 1 country: Iran