Probiotics for Blepharitis in Adults and Children

Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04742855
• Other study ID #: 01/2021
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: January 18, 2022

Study information

• Verified date: February 2021
• Source: University of Molise
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 80 Years

Eligibility

Inclusion Criteria:

• blepharitis

Exclusion Criteria:

• eyelid infection

• suspicion of malignancy

Related Conditions & MeSH terms

• Blepharitis

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Molise	Campobasso

Sponsors (1)

Lead Sponsor	Collaborator
University of Molise

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Cavuoto KM, Banerjee S, Galor A. Relationship between the microbiome and ocular health. Ocul Surf. 2019 Jul;17(3):384-392. doi: 10.1016/j.jtos.2019.05.006. Epub 2019 May 21. Review. — View Citation

Filippelli M, dell'Omo R, Amoruso A, Paiano I, Pane M, Napolitano P, Bartollino S, Costagliola C. Intestinal microbiome: a new target for chalaziosis treatment in children? Eur J Pediatr. 2020 Nov 23. doi: 10.1007/s00431-020-03880-5. [Epub ahead of print] — View Citation

Floyd JL, Grant MB. The Gut-Eye Axis: Lessons Learned from Murine Models. Ophthalmol Ther. 2020 Sep;9(3):499-513. doi: 10.1007/s40123-020-00278-2. Epub 2020 Jul 2. Review. — View Citation

Lu LJ, Liu J. Human Microbiota and Ophthalmic Disease. Yale J Biol Med. 2016 Sep 30;89(3):325-330. eCollection 2016 Sep. Review. — View Citation

Moon J, Choi SH, Yoon CH, Kim MK. Gut dysbiosis is prevailing in Sjögren's syndrome and is related to dry eye severity. PLoS One. 2020 Feb 14;15(2):e0229029. doi: 10.1371/journal.pone.0229029. eCollection 2020. — View Citation

Moon J, Yoon CH, Choi SH, Kim MK. Can Gut Microbiota Affect Dry Eye Syndrome? Int J Mol Sci. 2020 Nov 10;21(22). pii: E8443. doi: 10.3390/ijms21228443. Review. — View Citation

Ochoa-Repáraz J, Kasper LH. The influence of gut-derived CD39 regulatory T cells in CNS demyelinating disease. Transl Res. 2017 Jan;179:126-138. doi: 10.1016/j.trsl.2016.07.016. Epub 2016 Jul 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blepharitis recurrence	assessment of the number of recurrences during the time frame of the study	six months
Primary	Blepharitis resolution time	assessment of the number of days required for full resolution of the blepharitis	six months
Secondary	systemic inflammatory profile	After venous sampling, the following biomarker will be analysed with a cytometer: TNFa (pg/mL) .	six months
Secondary	systemic inflammatory profile	After venous sampling, the following biomarker will be analysed with a cytometer: lymphocyte subpopulations (cells/mcL).	six months