An observational study in Blepharitis, sponsored by University of Molise. Status unknown at 1 site in Italy. Open to participants aged 8 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by University of Molise · Observational
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.
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
Browse Blepharitis studies →University of Molise is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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The patients with blepharitis will be divided into three groups of 15 each (each group will be composed of 10 adults and 5 children)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
It will consist of 10 adults and 5 children. They will get the yogurt strains
Dietary Supplement: Probiotics
It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains.
Dietary Supplement: Probiotics
It will consist of 10 adults and 5 children. They will get the placebo.
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.
Blepharitis recurrence
assessment of the number of recurrences during the time frame of the study
Time frame: six months
Blepharitis resolution time
assessment of the number of days required for full resolution of the blepharitis
Time frame: six months
systemic inflammatory profile
After venous sampling, the following biomarker will be analysed with a cytometer: TNFα (pg/mL) .
Time frame: six months
systemic inflammatory profile
After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL).
Time frame: six months
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University of Molise