Efficacy and Safety of Systemic and Ophthalmic Probiotic on Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •18<age<60
- •BCVA (Best Corrected Visual Acuity) >=9/10
- •At least 2 subjective complaints compatible with dry eye
- •TBUT (Tear Break-Up Time) <= 10 sec, Schirmer's test <= 10mm
- •Signed informed consent, voluntary adherence to treatment
排除标准
- •Pregnancy/breastfeeding
- •Conjunctivitis
- •Thyroid disease
- •Rheumatologic diseases including Sjogren's syndrome
- •Neurologic conditions, including stroke, Bell's palsy, Parkinson's, trigeminal nerve problem
- •Refractive surgery (LASIK or PRK)
- •Other Eye Surgeries
- •HSV Keratitis
- •Medication/supplement use, including psychiatric medicines, OTC cold medicines, anti-histamines, beta-blockers, pain relievers, sleeping pills, diuretics, Hormones replacement, and oral contraceptives
- •Chemical splashes / injuries to the eyes
- •Contact lens use
- •Environmental (dusty, windy, hot/dry)
- •Any treatment for dry eye in previous 4 weeks (including lubricants, steroids, cyclosporine)
研究组 & 干预措施
Ophthalmic probiotic
1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
干预措施: Ophthalmic Probiotic (Drug)
Ophthalmic probiotic
1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
干预措施: Oral Placebo Capsule (Dietary Supplement)
Placebo
1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
干预措施: Opthalmic Placebo (Drug)
Placebo
1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
干预措施: Oral Placebo Capsule (Dietary Supplement)
Opthalmic Probiotic + Oral Probiotic
1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
干预措施: Ophthalmic Probiotic (Drug)
Opthalmic Probiotic + Oral Probiotic
1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
干预措施: Oral Probiotic Capsule (Dietary Supplement)
Oral Probiotic
1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
干预措施: Opthalmic Placebo (Drug)
Oral Probiotic
1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
干预措施: Oral Probiotic Capsule (Dietary Supplement)
结局指标
主要结局
Ocular Surface Disease Index
时间窗: 4 weeks
Subjective score
次要结局
- Ocular surface microbiota composition(4 weeks)
- Tear Interleukin level(4 weeks)
- Tear break up time (TBUT)(4 weeks)
- Schirmer test(4 weeks)
研究者
Mojtaba Heydari
Principal Investigator
Shiraz University of Medical Sciences