Clinical Trials Directory

Trials / Unknown

UnknownNCT04742855

Probiotics for Blepharitis in Adults and Children

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

Status
Unknown
Phase
Study type
Observational
Enrollment
45 (estimated)
Sponsor
University of Molise · Academic / Other
Sex
All
Age
8 Years – 80 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTProbioticsStudy 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.

Timeline

Start date
2021-01-18
Primary completion
2022-01-18
Completion
2022-01-18
First posted
2021-02-08
Last updated
2021-02-08

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04742855. Inclusion in this directory is not an endorsement.