Probiotics for Chalaziosis Treatment in Children

• Sponsor: University of Molise (Other)
• Overall Status: Completed
• CT.gov ID: NCT04322500
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chalazion	Dietary Supplement: probiotics; Other: conservative treatment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective comparative pilot study with two groups randomly dividedProspective comparative pilot study with two groups randomly divided
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Feb 29, 2020
• Actual Study Completion Date: Feb 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Group A: conservative conservative treatment	Other: conservative treatment; lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
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)	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

Outcome Measures

Primary Outcome Measures

1. Time Taken for a Complete Resolution of the Chalaziosis [3 months]

   change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)

2. Number of Recurrences [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Molise	Campobasso		Italy

Sponsors and Collaborators

• University of Molise

Investigators

• Principal Investigator: Ciro Costagliola, Full Professor, University of Molise

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 7, 2019

More Information

Additional Information:

• probiotics definition
• Infective and Inflammatory Eyelid Disorders: Conventional and Unconventional Therapies to Maintain Eye Health and Avoid Lid Surgery

Publications

• 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. Review.
• Iovieno A, Lambiase A, Sacchetti M, Stampachiacchiere B, Micera A, Bonini S. Preliminary evidence of the efficacy of probiotic eye-drop treatment in patients with vernal keratoconjunctivitis. Graefes Arch Clin Exp Ophthalmol. 2008 Mar;246(3):435-41. Epub 2007 Nov 27.
• Kalyana Chakravarthy S, Jayasudha R, Sai Prashanthi G, Ali MH, Sharma S, Tyagi M, Shivaji S. Dysbiosis in the Gut Bacterial Microbiome of Patients with Uveitis, an Inflammatory Disease of the Eye. Indian J Microbiol. 2018 Dec;58(4):457-469. doi: 10.1007/s12088-018-0746-9. Epub 2018 Jun 4.
• Kerry RG, Patra JK, Gouda S, Park Y, Shin HS, Das G. Benefaction of probiotics for human health: A review. J Food Drug Anal. 2018 Jul;26(3):927-939. doi: 10.1016/j.jfda.2018.01.002. Epub 2018 Feb 2. Review.
• 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. Review.
• 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.
• 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.
• Lu LJ, Liu J. Human Microbiota and Ophthalmic Disease. Yale J Biol Med. 2016 Sep 30;89(3):325-330. eCollection 2016 Sep. Review.
• 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.
• McLean MH, Dieguez D Jr, Miller LM, Young HA. Does the microbiota play a role in the pathogenesis of autoimmune diseases? Gut. 2015 Feb;64(2):332-41. doi: 10.1136/gutjnl-2014-308514. Epub 2014 Nov 21. Review.
• 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.
• 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. Review.
• Scher JU, Littman DR, Abramson SB. Microbiome in Inflammatory Arthritis and Human Rheumatic Diseases. Arthritis Rheumatol. 2016 Jan;68(1):35-45. doi: 10.1002/art.39259. Review.
• 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.
• 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.
• 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.

• Responsible Party: Ciro Costagliola, Full Professor in Ophthalmology, University of Molise
• ClinicalTrials.gov Identifier: NCT04322500
• Other Study ID Numbers: 07/2019
• First Posted: Mar 26, 2020
• Last Update Posted: May 5, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ciro Costagliola, Full Professor in Ophthalmology, University of Molise: microbiome/microbiota; probiotics; chalaziosis; children
• Additional relevant MeSH terms: Chalazion

Study Results

Participant Flow

Arm/Group Title	Group A: Conservative	Group B: Probiotics
Arm/Group Description	conservative treatment conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days	in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01) 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 conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Period Title: Overall Study
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group A: Conservative	Group B: Probiotics	Total
Arm/Group Description	conservative treatment conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days	in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01) 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 conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days	Total of all reporting groups
Overall Participants	13	13	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.9 (1.2)	8.6 (1.9)	8.3 (1.5)
Sex: Female, Male (Count of Participants)
Female	9 69.2%	8 61.5%	17 65.4%
Male	4 30.8%	5 38.5%	9 34.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	13 100%	13 100%	26 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Italy	13 100%	13 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Time Taken for a Complete Resolution of the Chalaziosis
Description	change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Conservative	Group B: Probiotics
Arm/Group Description	conservative treatment conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days	in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01) 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 conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Measure Participants	13	13
Mean (Standard Deviation) [days]	51.2 (12.4)	28.4 (10.8)

2. Primary Outcome

Title	Number of Recurrences
Description	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)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Conservative	Group B: Probiotics
Arm/Group Description	conservative treatment conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days	in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01) 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 conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Measure Participants	13	13
Number [recurreces]	0	0

Adverse Events

Time Frame	1 year
Arm/Group Title	Group A: Conservative		Group B: Probiotics
Arm/Group Description	conservative treatment conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days		in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01) 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 conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
All Cause Mortality
	Group A: Conservative		Group B: Probiotics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Serious Adverse Events
	Group A: Conservative		Group B: Probiotics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Group A: Conservative		Group B: Probiotics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)

Limitations/Caveats

Further studies are needed to confirm this first pilot trial (larger cohort, ocular and gut microbiome analysis).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.