Probiotics for Blepharitis in Adults and Children

University of Molise

Status: Unknown

Conditions: Blepharitis

Treatments: Dietary Supplement: Probiotics

Study type: Observational

Funder types: Other

Identifiers

NCT04742855

01/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 8 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• blepharitis

Exclusion criteria

• eyelid infection
• suspicion of malignancy

Trial design

45 participants in 3 patient groups

Group A

Description:

It will consist of 10 adults and 5 children. They will get the yogurt strains

Treatment:

Dietary Supplement: Probiotics

Group B

Description:

It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains.

Treatment:

Dietary Supplement: Probiotics

Group C

Description:

It will consist of 10 adults and 5 children. They will get the placebo.