Clinical trial NCT04742855: Probiotics for Blepharitis in Adults and Children
Official title: Effect of Probiotics on the Occurrence of Blepharitis in Adults and Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blepharitis
Keywords: microbiome/microbiota
probiotics
Lead sponsor: University of Molise
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: Inclusion Criteria:

* blepharitis

Exclusion Criteria:

* eyelid infection
* suspicion of malignancy

Primary outcomes:
measure: Blepharitis recurrence
timeFrame: six months
measure: Blepharitis resolution time
timeFrame: six months
Secondary outcomes:
measure: systemic inflammatory profile
timeFrame: six months
measure: systemic inflammatory profile
timeFrame: six months
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: University of Molise
Study officials:
References:
citation: Lu LJ, Liu J. Human Microbiota and Ophthalmic Disease. Yale J Biol Med. 2016 Sep 30;89(3):325-330. eCollection 2016 Sep.
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.
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):8443. doi: 10.3390/ijms21228443.
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. 2021 Apr;180(4):1293-1298. doi: 10.1007/s00431-020-03880-5. Epub 2020 Nov 23.
citation: Ochoa-Reparaz 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.
citation: 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.
citation: Moon J, Choi SH, Yoon CH, Kim MK. Gut dysbiosis is prevailing in Sjogren'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.