Probiotics for Chalaziosis Treatment in Children

Overview

There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.

Full Title of Study: “Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 29, 2020

Detailed Description

Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results.

Interventions

  • Dietary Supplement: probiotics
    • use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis
  • Other: conservative treatment
    • lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days

Arms, Groups and Cohorts

  • Other: Group A: conservative
    • conservative treatment
  • Experimental: Group B: probiotics
    • in addition to the conservative treatment they receive a probiotics mixture (Streptococcus thermophilus ST10, Lactococcus lactis LLCO2 and Lactobacillus delbrueckii subsp. bulgaricus LDB01)

Clinical Trial Outcome Measures

Primary Measures

  • Time Taken for a Complete Resolution of the Chalaziosis
    • Time Frame: 3 months
    • change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
  • Number of Recurrences
    • Time Frame: 3 months
    • complete ophthalmological evaluation was done weekly during the first month and then monthly in order to evaluate possible recurrences (presence of a new eyelid mass lesion)

Participating in This Clinical Trial

Inclusion Criteria

  • paediatric patients – presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months) Exclusion Criteria:

  • eyelid infection – chalazion duration < 1 month – nonpalpable chalazion – suspicion of malignancy

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Molise
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ciro Costagliola, Full Professor in Ophthalmology – University of Molise
  • Overall Official(s)
    • Ciro Costagliola, Full Professor, Principal Investigator, University of Molise

References

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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.

Baim AD, Movahedan A, Farooq AV, Skondra D. The microbiome and ophthalmic disease. Exp Biol Med (Maywood). 2019 Apr;244(6):419-429. doi: 10.1177/1535370218813616. Epub 2018 Nov 21.

Kugadas A, Gadjeva M. Impact of Microbiome on Ocular Health. Ocul Surf. 2016 Jul;14(3):342-9. doi: 10.1016/j.jtos.2016.04.004. Epub 2016 May 14.

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.

Sansotta N, Peroni DG, Romano S, Rugiano A, Vuilleumier P, Baviera G; Italian Society of Pediatric Allergy, Immunology (SIAIP), Microbiota Committee, Italy. The good bugs: the use of probiotics in pediatrics. Curr Opin Pediatr. 2019 Oct;31(5):661-669. doi: 10.1097/MOP.0000000000000808.

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.

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.

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.

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

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