Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
Phase: NA
Conditions: Chalazion
Sponsor: University of Molise

 
PROTOCOL: Probiotics for Chalaziosis Treatment in Children 
 
Approval number: 07/19  
Approved by CTS of Department of Medicine and Health Sciences “V. Tiberio” of 
Molise University on the 07 th January, 2019 
The trial was registered at clinical trials.gov as NCT04322500 on the 25 th March, 
2020 (“retrospectively registered”) 
 
PURPOSE: Human gut holds over 100–1000 microbial species, which primarily 
modulate the host internal environment and thereby, play a major role in host health.  
Supplementation with probiotics has shown promising results against various enteric 
pathogens thanks to their unique ability to compete with pathogenic microbiota for 
adhesion sites, to alienate pathogens or to stimulate, modulate and regulate the host's 
immune response by initiating the activation of specific genes in and outside the host 
intestinal tract. [R. G. Kerry et al, Benefaction of probiotics for human health: 
A review,  2018] In recent years, intestinal microbiota emerged as a candidate 
responsible for providing innate stimuli to prime the immune system, and its 
contribution to pathogenesis of autoimmune diseases has been intensively studied. 
Clinical studies support a link between changes in gut commensal microbiota 
(‘dysbiosis’) and human autoimmune diseases including rheumatoid arthritis, 
spondyloarthritis, lupus, diabetes, inflammatory bowel disease and multiple sclerosis  
[McLean MH, Dieguez D Jr, Miller LM, et al. Does the microbiota play a role in the 
pathogenesis of autoimmune diseases? Gut 2015; Scher JU, Littman DR, Abramson 
SB. Microbiome in inflammatory arthritis and human rheumatic diseases. Arthritis 
Rheumato2016;  Ochoa-Reparaz J, Kasper LH. The influence of gut-derived CD39 
regulatory T cells in CNS demyelinating disease. Transl Res 2017]. Moreover, animal 
studies on autoimmune uveitis in rodents have unraveled strong associations of gut 
microbiota with disease. Also ocular conditions such as chalazia are linked to 
dysbiosis [Infective and Inflammatory Eyelid Disorders: Conventional and 
Unconventional Therapies to Maintain Eye Health and Avoid Lid Surgery; A. L. 
Giacomin , EC Ophthalmology 2016].  Moreover, it is well known that any eating 
disorders such as excessive use of saturated fats, can result in a change in the 
composition of the secreted fat of the Meibomian glands, making it less fluid. So it 
becomes difficult to spill the glandular secretion leading to chalazia formation. The 

correlation between inflammatory conditions of the conjunctival membrane, lacrimal 
dysfunctions and an intestinal immune condition featuring dysbiosis are 
phatophysiologucal conditions of great interest and are currently analysed.To the best 
of our knoledge there are no studies on probiotics suplementation in halaziosis. 
Moreover, several evidence demonstrate that probiotics may play a role in the 
prevention and treatment of different conditions not only in adults, but also in 
children. In the latter population acute diarrhea is an important application of 
probiotics (Lactobacillus rhamnosus and Saccharomyces boulardii reduce the 
duration of gastroenteritis by approximately 24 h) [The good bugs: the use of 
probiotics in pediatrics.  Sansotta N, Curr Opin Pediatr.2019]. Hence, this study 
aims to define the possible beneficial impact of probiotics on children suffering from 
chalaziosis. 
DESIGN: This is a simple blind obsevational study. Paediatric patients affected by 
chalaziosis will be recruited. These patients will be divided in two groups, one 
receiving a supplementation with probiotics and the other one not.  Prior to 
enrollment in the study all patients will undergo a complete ophthalmological 
examination which includes : visual acuity test, slit lamp for annexes and anterior 
segment assessment, ocular fundus examination, intra ocular pression measurement. 
Subsequently a complete ophthalmological evaluation will be done weekly during the 
first month and then monthly until the healing. The ophthalmologist will be masked.  
ATTENDED RESULTS: Altering the intestinal microbioma with specific probiotics 
can ameliorate the clinical course of chalaziosis by re-estabilishing intestinal and 
immune homeostasis. So, we expect to observe a reduction or absence of the 
recurrencies of  chalazia. 
CONCLUSIONS: The use of probiotics for clinical health benefits is a 
fascinating area of research that the present era has yet to explore. Some of 
the elite properties of probiotics, such as anti-pathogenicity, anti-diabetic, 
anti-obesity, anti-inflammatory, anti-cancer, anti-allergic, and angiogenic 
activities and their effect on the brain and central nervous system are quite 
known. This study will provide further informations on probiotics and human 
health. Moreover, the intestinal microbiota are potentially crucial in 
spreading inflammatory disease of the eye, and can be targeted for 
therapeutic effects. So, throughout our study will be highlighted that 
probiotics supplementation could increase the effectiveness of traditional 
therapies in reducing recurrencies of chalaziosis in an easy and feasible way. 

Statistical Analysis Plan 
Mann Whitney 𝑈 test will be used in order to analyze if there will be a 
significative difference  between the two groups in: 
- Time taken for complete resolution of the chalazion  
- Number of recurrences