Probiotics for Chalaziosis Treatment in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children

Conditions
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Chalazion

Intervention / Treatment
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* Dietary Supplement: probiotics
* Other: conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective comparative pilot study with two groups randomly divided
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: conservative<br>conservative treatment | Other: conservative treatment<br>* lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days<br>|
| Experimental: Group B: probiotics<br>in addition to the conservative treatment they receive a probiotics mixture (Streptococcus thermophilus ST10, Lactococcus lactis LLCO2 and Lactobacillus delbrueckii subsp. bulgaricus LDB01) | Dietary Supplement: probiotics<br>* use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis<br>Other: conservative treatment<br>* lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Taken for a Complete Resolution of the Chalaziosis | change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions) | 3 months | 
| Number of Recurrences | 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) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome/microbiota, probiotics, chalaziosis, children