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临床试验/NCT04742855
NCT04742855Unknown不适用

Effect of Probiotics on the Occurrence of Blepharitis in Adults and Children

University of Molise1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年1月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Blepharitis resolution time

研究概览

简要总结

The alteration of the intestinal microbiota through the use of specific probiotics can improve the clinical course of blepharitis by restoring intestinal and immune homeostasis. The purpose of this study is to define the possible positive impact of probiotics on patients with blepharitis.

详细描述

From recent studies, it has emerged that the gut microbiota is a possible responsible for the stimulation of the innate immune response and its role in the pathogenesis of autoimmune diseases has been deepened. Several clinical studies, in fact, support the existence of a connection between changes in the commensal intestinal microbiota ("dysbiosis") and autoimmune diseases. It has been seen that also ocular conditions like chalaziosis and uveitis are tied to dysbiosis. In addition, in a recent study probiotics were found to be safe and effective in the treatment of chalaziosis in children. Other eye conditions that may be affected by changes in the gut microbiome are dry eye syndrome and blepharitis. Under these conditions, a reduction in globet cells has often been noted. These cells produce the mucins present on the ocular surface, and therefore, their reduction involves the production of a thin and ineffective tear film. Therefore, the study will cover patients with blepharitis (both adults and children), treated with specific probiotics to be taken daily. Patients will then undergo a full ophthalmological examination each week for the first month, and then monthly until complete recovery for at least 6 months. In addition, at the time of enlistment and complete recovery, after venous sampling, the following biomarkers will be analyzed with cytometer and ELISA: TNFα and lymphocyte subpopulations. With this study, therefore, the aim is to define the possible positive impact of probiotics on patients with blepharitis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
8 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • blepharitis

排除标准

  • eyelid infection
  • suspicion of malignancy

结局指标

主要结局

Blepharitis resolution time

时间窗: six months

assessment of the number of days required for full resolution of the blepharitis

Blepharitis recurrence

时间窗: six months

assessment of the number of recurrences during the time frame of the study

次要结局

  • systemic inflammatory profile(six months)

研究者

发起方
University of Molise
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciro Costagliola

Full Professor in Ophthalmology

University of Molise

研究点 (1)

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