Probiotics for Blepharitis in Adults and Children

Sponsor
University of Molise (Other)
Overall Status
Recruiting
CT.gov ID
NCT04742855
Collaborator
(none)
45
1
12
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotics

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 Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Effect of Probiotics on the Occurrence of Blepharitis in Adults and Children
Actual Study Start Date :
Jan 18, 2021
Anticipated Primary Completion Date :
Jan 18, 2022
Anticipated Study Completion Date :
Jan 18, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Blepharitis recurrence [six months]

    assessment of the number of recurrences during the time frame of the study

  2. Blepharitis resolution time [six months]

    assessment of the number of days required for full resolution of the blepharitis

Secondary Outcome Measures

  1. systemic inflammatory profile [six months]

    After venous sampling, the following biomarker will be analysed with a cytometer: TNFα (pg/mL) .

  2. systemic inflammatory profile [six months]

    After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL).

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • blepharitis
Exclusion Criteria:
  • eyelid infection

  • suspicion of malignancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Molise Campobasso Italy

Sponsors and Collaborators

  • University of Molise

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ciro Costagliola, Full Professor in Ophthalmology, University of Molise
ClinicalTrials.gov Identifier:
NCT04742855
Other Study ID Numbers:
  • 01/2021
First Posted:
Feb 8, 2021
Last Update Posted:
Feb 8, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ciro Costagliola, Full Professor in Ophthalmology, University of Molise
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2021