Probiotics for Treatment of Chalazion in Adults

Study Overview
=================
Brief Summary
-----------------
There is growing evidence encouraging probiotics use in several diseases. The aim of the investigator's study is to define the possible beneficial impact of probiotics on adults suffering from chalazia.

Detailed Description
-----------------
Prospective comparative pilot study on 20 adults suffering from chalazion randomly divided into two groups. The first group, received conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days. The second group, in addition to the conservative treatment, received a mixture of probiotic microorganisms once a day up to 3 months. Chalazia were classified according to their size into three groups: small (≤2 mm), medium (2-4 mm), or large (>4 mm). When conservative treatment (with and without probiotics supplementation) failed to resolve the lesion, invasive methods were used, (intralesion steroid injection in medium size chalazion and surgical incision and curettage for the largest ones).

Official Title
-----------------
Effects of Probiotic Oral Supplementation on the Treatment of Chalazion in Adults: a Pilot Study on 20 Patients

Conditions
-----------------
Chalazion

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months clinical appearance and location of the lesion Exclusion Criteria: eyelid infection chalazion duration < 1 month nonpalpable chalazion suspicion of malignancy comorbidities (constitutional atopy and seborrheic dermatitis, hormonal dysfunction, presence of irritable bowel disease, infectious mainly related to Staphylococcus aureus and Propionibacterium acnes, demodex mite infestation, vitamin A deficiency, arterial hypertension, diabetes and pregnancy) personal habits (smoking, eating disorders, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days | 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 probiotics mixture (Streptococcus thermophilus, Lactococcus lactis, Lactobacillus delbrueckii subsp. bulgaricus) once a day up to 3 months. | Other: conservative treatment<br>* lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.<br>Dietary Supplement: probiotics<br>* use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of adults chalazia by re-establishing intestinal and immune homeostasis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing time | healing time changes with a complete resolution of chalazion | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrences | evaluation of recurrences in both arms | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome/microbiota, probiotics, adults