Probiotics for Blepharitis in Adults and Children

February 3, 2021 updated by: Ciro Costagliola, University of Molise

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Campobasso, Italy
        • Recruiting
        • University of Molise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients with blepharitis will be divided into three groups of 15 each (each group will be composed of 10 adults and 5 children)

Description

Inclusion Criteria:

  • blepharitis

Exclusion Criteria:

  • eyelid infection
  • suspicion of malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
It will consist of 10 adults and 5 children. They will get the yogurt strains
Dietary supplement: Probiotics
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.
Group B
It will consist of 10 adults and 5 children. They will get the Bifidobacterium strains.
Dietary supplement: Probiotics
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.
Group C
It will consist of 10 adults and 5 children. They will get the placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blepharitis recurrence
Time Frame: six months
assessment of the number of recurrences during the time frame of the study
six months
Blepharitis resolution time
Time Frame: six months
assessment of the number of days required for full resolution of the blepharitis
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systemic inflammatory profile
Time Frame: six months
After venous sampling, the following biomarker will be analysed with a cytometer: TNFα (pg/mL) .
six months
systemic inflammatory profile
Time Frame: six months
After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL).
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Molise

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Anticipated)

January 18, 2022

Study Completion (Anticipated)

January 18, 2022

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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