Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chalazion
- Sponsor
- University of Molise
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Time Taken for a Complete Resolution of the Chalaziosis
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ciro Costagliola
Full Professor in Ophthalmology
University of Molise
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •eyelid infection
- •chalazion duration \< 1 month
- •nonpalpable chalazion
- •suspicion of malignancy
Outcomes
Primary Outcomes
Time Taken for a Complete Resolution of the Chalaziosis
Time Frame: 3 months
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Number of Recurrences
Time Frame: 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)