Probiotics for Blepharitis in Adults and Children
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Group A It will consist of 10 adults and 5 children. They will get the yogurt strains |
Dietary Supplement: Probiotics
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.
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Group B It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains. |
Dietary Supplement: Probiotics
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.
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Group C It will consist of 10 adults and 5 children. They will get the placebo. |
Outcome Measures
Primary Outcome Measures
- Blepharitis recurrence [six months]
assessment of the number of recurrences during the time frame of the study
- Blepharitis resolution time [six months]
assessment of the number of days required for full resolution of the blepharitis
Secondary Outcome Measures
- systemic inflammatory profile [six months]
After venous sampling, the following biomarker will be analysed with a cytometer: TNFα (pg/mL) .
- systemic inflammatory profile [six months]
After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL).
Eligibility Criteria
Criteria
Inclusion Criteria:
- blepharitis
Exclusion Criteria:
-
eyelid infection
-
suspicion of malignancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Molise | Campobasso | Italy |
Sponsors and Collaborators
- University of Molise
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01/2021