Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-02-01
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group A: conservative
conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
conservative treatment
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.
Group B: probiotics
in addition to the conservative treatment they receive probiotics mixture (Streptococcus thermophilus, Lactococcus lactis, Lactobacillus delbrueckii subsp. bulgaricus) once a day up to 3 months.
conservative treatment
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.
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
Interventions
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conservative treatment
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.
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
Eligibility Criteria
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Inclusion Criteria
* clinical appearance and location of the lesion
Exclusion Criteria
* 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.)
18 Years
65 Years
ALL
No
Sponsors
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University of Molise
OTHER
Responsible Party
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Ciro Costagliola
Full Professor in Ophthalmology
Principal Investigators
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Ciro Costagliola, Full Professor
Role: PRINCIPAL_INVESTIGATOR
University of Molise
Locations
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University of Molise
Campobasso, Molise, Italy
Countries
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References
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Gilchrist H, Lee G. Management of chalazia in general practice. Aust Fam Physician. 2009 May;38(5):311-4.
Unal M. Chalazion treatment. Orbit. 2008;27(6):397-8. doi: 10.1080/01676830802623174. No abstract available.
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.
Nemet AY, Vinker S, Kaiserman I. Associated morbidity of chalazia. Cornea. 2011 Dec;30(12):1376-81. doi: 10.1097/ICO.0b013e31821de36f.
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.
Burkhart CG, Burkhart CN. Similar to acne vulgaris, bacteria may produce the biological glue that causes plugging of the meibomian gland leading to chalazions. Clin Exp Ophthalmol. 2008 Apr;36(3):295; author reply 295-6. doi: 10.1111/j.1442-9071.2008.01714.x. No abstract available.
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.
Nabie R, Soleimani H, Nikniaz L, Raoufi S, Hassanpour E, Mamaghani S, Bahremani E. A prospective randomized study comparing incision and curettage with injection of triamcinolone acetonide for chronic chalazia. J Curr Ophthalmol. 2019 May 7;31(3):323-326. doi: 10.1016/j.joco.2019.04.001. eCollection 2019 Sep.
Lee JW, Yau GS, Wong MY, Yuen CY. A comparison of intralesional triamcinolone acetonide injection for primary chalazion in children and adults. ScientificWorldJournal. 2014;2014:413729. doi: 10.1155/2014/413729. Epub 2014 Oct 15.
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.
Han KJ, Lee JE, Lee NK, Paik HD. Antioxidant and Anti-Inflammatory Effect of Probiotic Lactobacillus plantarum KU15149 Derived from Korean Homemade Diced-Radish Kimchi. J Microbiol Biotechnol. 2020 Apr 28;30(4):591-598. doi: 10.4014/jmb.2002.02052.
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.
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.
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.
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.
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.
Cavuoto KM, Banerjee S, Galor A. Relationship between the microbiome and ocular health. Ocul Surf. 2019 Jul;17(3):384-392. doi: 10.1016/j.jtos.2019.05.006. Epub 2019 May 21.
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.
Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.
Ozdal PC, Codere F, Callejo S, Caissie AL, Burnier MN. Accuracy of the clinical diagnosis of chalazion. Eye (Lond). 2004 Feb;18(2):135-8. doi: 10.1038/sj.eye.6700603.
Ozkan J, Willcox MD. The Ocular Microbiome: Molecular Characterisation of a Unique and Low Microbial Environment. Curr Eye Res. 2019 Jul;44(7):685-694. doi: 10.1080/02713683.2019.1570526. Epub 2019 Feb 4.
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/iovs.17-22957.
Grzybowski A, Brona P, Kim SJ. Microbial flora and resistance in ophthalmology: a review. Graefes Arch Clin Exp Ophthalmol. 2017 May;255(5):851-862. doi: 10.1007/s00417-017-3608-y. Epub 2017 Feb 22.
Lu LJ, Liu J. Human Microbiota and Ophthalmic Disease. Yale J Biol Med. 2016 Sep 30;89(3):325-330. eCollection 2016 Sep.
Rosenbaum JT, Lin P, Asquith M. The microbiome, HLA, and the pathogenesis of uveitis. Jpn J Ophthalmol. 2016 Jan;60(1):1-6. doi: 10.1007/s10384-015-0416-y. Epub 2015 Sep 14.
Nayyar A, Gindina S, Barron A, Hu Y, Danias J. Do epigenetic changes caused by commensal microbiota contribute to development of ocular disease? A review of evidence. Hum Genomics. 2020 Mar 13;14(1):11. doi: 10.1186/s40246-020-00257-5.
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 Altered Composition of Leukocyte Subsets to Noninfectious Uveitis. Invest Ophthalmol Vis Sci. 2018 Feb 1;59(2):878-888. doi: 10.1167/iovs.17-23643.
Forbes JD, Chen CY, Knox NC, Marrie RA, El-Gabalawy H, de Kievit T, Alfa M, Bernstein CN, Van Domselaar G. A comparative study of the gut microbiota in immune-mediated inflammatory diseases-does a common dysbiosis exist? Microbiome. 2018 Dec 13;6(1):221. doi: 10.1186/s40168-018-0603-4.
Trujillo-Vargas CM, Schaefer L, Alam J, Pflugfelder SC, Britton RA, de Paiva CS. The gut-eye-lacrimal gland-microbiome axis in Sjogren Syndrome. Ocul Surf. 2020 Apr;18(2):335-344. doi: 10.1016/j.jtos.2019.10.006. Epub 2019 Oct 20.
Kugadas A, Wright Q, Geddes-McAlister J, Gadjeva M. Role of Microbiota in Strengthening Ocular Mucosal Barrier Function Through Secretory IgA. Invest Ophthalmol Vis Sci. 2017 Sep 1;58(11):4593-4600. doi: 10.1167/iovs.17-22119.
Related Links
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MicroRNAs and microbiota: Is there a cross talk?
Other Identifiers
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08/2019
Identifier Type: -
Identifier Source: org_study_id
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