Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time Taken for a Complete Resolution of the Chalaziosis
研究概览
简要总结
There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.
详细描述
Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •paediatric patients
- •presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months)
排除标准
- •eyelid infection
- •chalazion duration < 1 month
- •nonpalpable chalazion
- •suspicion of malignancy
结局指标
主要结局
Time Taken for a Complete Resolution of the Chalaziosis
时间窗: 3 months
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Number of Recurrences
时间窗: 3 months
complete ophthalmological evaluation was done weekly during the first month and then monthly in order to evaluate possible recurrences (presence of a new eyelid mass lesion)
次要结局
未报告次要终点
研究者
Ciro Costagliola
Full Professor in Ophthalmology
University of Molise