Probiotics for Blepharitis in Adults and Children

• Conditions: Blepharitis
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT04742855
• Lead Sponsor: University of Molise

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.

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 Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-01-29
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Study First Posted: 2021-02-08
• Last Update Posted: 2021-02-08
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• blepharitis

Exclusion Criteria

• eyelid infection
• suspicion of malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Probiotics	It will consist of 10 adults and 5 children. They will get the yogurt strains
Group B	Probiotics	It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains.

Primary Outcome Measures

Name	Time	Method
Blepharitis resolution time	six months	assessment of the number of days required for full resolution of the blepharitis
Blepharitis recurrence	six months	assessment of the number of recurrences during the time frame of the study

Secondary Outcome Measures

Name	Time	Method
systemic inflammatory profile	six months	After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL).

Trial Locations

Locations (1)

University of Molise; 🇮🇹 Campobasso, Italy