Probiotics for Chalaziosis Treatment in Children

NCT04322500 | Completed Results

• 1 other identifier: 07/2019
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Chalazion

Keywords

microbiome/microbiota; probiotics; chalaziosis; children

Outcome Measures

Primary Outcomes (2)

• Time Taken for a Complete Resolution of the Chalaziosis

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

  3 months

• Number of Recurrences

  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)

  3 months

Study Arms (2)

Group A: conservative

OTHER

conservative treatment

Other: conservative treatment

Group B: probiotics

EXPERIMENTAL

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; Other: conservative treatment

Interventions

probiotics DIETARY_SUPPLEMENT

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

Group B: probiotics

conservative treatment OTHER

lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days

Group A: conservative; Group B: probiotics

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Molise: lead

Study Sites (1)

University of Molise

Campobasso, Italy

Location

Related Publications (16)

• 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.

  PMID: 29976412 BACKGROUND

• 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.

  PMID: 25416067 BACKGROUND

• 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. No abstract available.

  PMID: 26331579 BACKGROUND

• 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.

  PMID: 27519147 BACKGROUND

• 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.

  PMID: 30262956 BACKGROUND

• 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. doi: 10.1007/s00417-007-0682-6. Epub 2007 Nov 27.

  PMID: 18040708 BACKGROUND

• 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):88. doi: 10.3390/antibiotics8030088.

  PMID: 31262073 BACKGROUND

• 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.

  PMID: 29538183 BACKGROUND

• 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.

  PMID: 30463439 BACKGROUND

• 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.

  PMID: 27189865 BACKGROUND

• 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.

  PMID: 30834680 BACKGROUND

• 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.

  PMID: 31356353 BACKGROUND

• 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.

  PMID: 31088416 BACKGROUND

• 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.

  PMID: 29392144 BACKGROUND

• 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.

  PMID: 23873491 BACKGROUND

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

  PMID: 27698616 BACKGROUND

Related Links

• probiotics definition

MeSH Terms

Conditions

Chalazion

Interventions

Probiotics; Conservative Treatment

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Therapeutics

Limitations and Caveats

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

Results Point of Contact

• Title: Prof. Ciro Costagliola
• Organization: University of Molise

ciro.costagliola@unimol.it

+39 0874 404861/ 0874 404896

Study Officials

• Ciro Costagliola, Full Professor

  University of Molise

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Ophthalmology

Model Details: Prospective comparative pilot study with two groups randomly divided

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: February 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: May 5, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)