Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742855
Status:
UNKNOWN
Last Update Posted:
2021-02-08
First Post:
2021-01-29
Brief Title:
Probiotics for Blepharitis in Adults and Children
Sponsor:
University of Molise
Organization:
University of Molise
Study Overview
Official Title:
Effect of Probiotics on the Occurrence of Blepharitis in Adults and Children
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None