Probiotics for Blepharitis in Adults and Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Blepharitis

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: blepharitis Exclusion Criteria: eyelid infection suspicion of malignancy

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>It will consist of 10 adults and 5 children. They will get the yogurt strains | Dietary Supplement: Probiotics<br>* Study product is packaged as powders in a sachet. Participants and their parents will be instructed to dissolve the powder in water or milk, and to drink it in the morning and/or evening.<br>|
| Group B<br>It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains. | Dietary Supplement: Probiotics<br>* Study product is packaged as powders in a sachet. Participants and their parents will be instructed to dissolve the powder in water or milk, and to drink it in the morning and/or evening.<br>|
| Group C<br>It will consist of 10 adults and 5 children. They will get the placebo. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blepharitis recurrence | assessment of the number of recurrences during the time frame of the study | six months | 
| Blepharitis resolution time | assessment of the number of days required for full resolution of the blepharitis | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic inflammatory profile | After venous sampling, the following biomarker will be analysed with a cytometer: TNFα (pg/mL) . | six months | 
| systemic inflammatory profile | After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL). | six months | 

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