Probiotics for Treatment of Chalazion in Adults

Chalazion Clinical Trial

Official title:

Effects of Probiotic Oral Supplementation on the Treatment of Chalazion in Adults: a Pilot Study on 20 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342507
• Other study ID #: 08/2019
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: April 2020
• Source: University of Molise
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is growing evidence encouraging probiotics use in several diseases. The aim of the investigator's study is to define the possible beneficial impact of probiotics on adults suffering from chalazia.

Description:

Prospective comparative pilot study on 20 adults suffering from chalazion randomly divided into two groups. The first group, received conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days. The second group, in addition to the conservative treatment, received a mixture of probiotic microorganisms once a day up to 3 months. Chalazia were classified according to their size into three groups: small (≤2 mm), medium (2-4 mm), or large (>4 mm). When conservative treatment (with and without probiotics supplementation) failed to resolve the lesion, invasive methods were used, (intralesion steroid injection in medium size chalazion and surgical incision and curettage for the largest ones).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months

• clinical appearance and location of the lesion

Exclusion Criteria:

• eyelid infection

• chalazion duration < 1 month

• nonpalpable chalazion

• suspicion of malignancy

• comorbidities (constitutional atopy and seborrheic dermatitis, hormonal dysfunction, presence of irritable bowel disease, infectious mainly related to Staphylococcus aureus and Propionibacterium acnes, demodex mite infestation, vitamin A deficiency, arterial hypertension, diabetes and pregnancy)

• personal habits (smoking, eating disorders, etc.)

Related Conditions & MeSH terms

• Chalazion

Intervention

Other:
• conservative treatment
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.

Dietary Supplement:
• probiotics
use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of adults chalazia by re-establishing intestinal and immune homeostasis

Locations

Country	Name	City	State
Italy	University of Molise	Campobasso	Molise

Sponsors (1)

Lead Sponsor	Collaborator
University of Molise

Country where clinical trial is conducted

Italy, 

References & Publications (31)

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Lin P. Importance of the intestinal microbiota in ocular inflammatory diseases: A review. Clin Exp Ophthalmol. 2019 Apr;47(3):418-422. doi: 10.1111/ceo.13493. Epub 2019 Mar 25. Review. — View Citation

Lin P. The role of the intestinal microbiome in ocular inflammatory disease. Curr Opin Ophthalmol. 2018 May;29(3):261-266. doi: 10.1097/ICU.0000000000000465. 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

Malekahmadi M, Farrahi F, Tajdini A. Serum Vitamin A Levels in Patients with Chalazion. Med Hypothesis Discov Innov Ophthalmol. 2017 Fall;6(3):63-66. — View Citation

Morrison DJ, Preston T. Formation of short chain fatty acids by the gut microbiota and their impact on human metabolism. Gut Microbes. 2016 May 3;7(3):189-200. doi: 10.1080/19490976.2015.1134082. Epub 2016 Mar 10. Review. — View Citation

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Sklar BA, Gervasio KA, Leng S, Ghosh A, Chari A, Wu AY. Management and outcomes of proteasome inhibitor associated chalazia and blepharitis: a case series. BMC Ophthalmol. 2019 May 14;19(1):110. doi: 10.1186/s12886-019-1118-x. — View Citation

Tavakoli A, Flanagan JL. The Case for a More Holistic Approach to Dry Eye Disease: Is It Time to Move beyond Antibiotics? Antibiotics (Basel). 2019 Jun 30;8(3). pii: E88. doi: 10.3390/antibiotics8030088. Review. — View Citation

Trujillo-Vargas CM, Schaefer L, Alam J, Pflugfelder SC, Britton RA, de Paiva CS. The gut-eye-lacrimal gland-microbiome axis in Sjögren Syndrome. Ocul Surf. 2020 Apr;18(2):335-344. doi: 10.1016/j.jtos.2019.10.006. Epub 2019 Oct 20. Review. — View Citation

Unal M. Chalazion treatment. Orbit. 2008;27(6):397-8. doi: 10.1080/01676830802623174. — View Citation

Verhagen FH, Bekker CPJ, Rossato M, Hiddingh S, de Vries L, Devaprasad A, Pandit A, Ossewaarde-van Norel J, Ten Dam N, Moret-Pot MCA, Imhof SM, de Boer JH, Radstake TRDJ, Kuiper JJW. A Disease-Associated MicroRNA Cluster Links Inflammatory Pathways and an — View Citation

Wen X, Miao L, Deng Y, Bible PW, Hu X, Zou Y, Liu Y, Guo S, Liang J, Chen T, Peng GH, Chen W, Liang L, Wei L. The Influence of Age and Sex on Ocular Surface Microbiota in Healthy Adults. Invest Ophthalmol Vis Sci. 2017 Dec 1;58(14):6030-6037. doi: 10.1167 — View Citation

Yam JC, Tang BS, Chan TM, Cheng AC. Ocular demodicidosis as a risk factor of adult recurrent chalazion. Eur J Ophthalmol. 2014 Mar-Apr;24(2):159-63. doi: 10.5301/ejo.5000341. Epub 2013 Jul 16. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing time	healing time changes with a complete resolution of chalazion	3 months
Secondary	recurrences	evaluation of recurrences in both arms	six months

External Links

•   Linear chalaziosis.
•   MicroRNAs and microbiota: Is there a cross talk?
•   Probiotic Agents and Infectious Diseases: A Modern Perspective on a Traditional Therapy