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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ophthalmic probiotic | Experimental | 1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks |
|
| Placebo | Placebo Comparator | 1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks |
|
| Opthalmic Probiotic + Oral Probiotic | Experimental | 1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks |
|
| Oral Probiotic | Experimental | 1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ophthalmic Probiotic | Drug | Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index | Subjective score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tear break up time (TBUT) | Slit exam | 4 weeks |
| Schirmer test | physical exam using Schirmer strip | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences | Shiraz | Fars | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37256485 | Derived | Heydari M, Kalani M, Ghasemi Y, Nejabat M. The Effect of Ophthalmic and Systemic Formulations of Latilactobacillus sakei on Clinical and Immunological Outcomes of Patients With Dry Eye Disease: A Factorial, Randomized, Placebo-controlled, and Triple-masking Clinical Trial. Probiotics Antimicrob Proteins. 2024 Jun;16(3):1026-1035. doi: 10.1007/s12602-023-10079-1. Epub 2023 May 31. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| 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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| Opthalmic Placebo | Drug | Placebo contains complete formulation of the active drug except for bacterial lysate of Lactobacillus sakei (i.e. HPMC, boric acid, sodium chloride, purified water) |
|
| Oral Probiotic Capsule | Dietary Supplement | Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient |
|
| Oral Placebo Capsule | Dietary Supplement | Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient |
|
| Ocular surface microbiota composition | measured by 16s rRNA method | 4 weeks |
| Tear Interleukin level | measured by ELISA | 4 weeks |
| D019602 |
| Food and Beverages |