Probiotics for Treatment of Chalazion in Adults

NCT04342507 | Completed

• 1 other identifier: 08/2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chalazion

Keywords

microbiome/microbiota; probiotics; adults

Outcome Measures

Primary Outcomes (1)

• healing time

  healing time changes with a complete resolution of chalazion

  3 months

Secondary Outcomes (1)

• recurrences

  six months

Study Arms (2)

Group A: conservative

OTHER

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

Other: conservative treatment

Group B: probiotics

EXPERIMENTAL

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.

Other: conservative treatment; Dietary Supplement: probiotics

Interventions

conservative treatment OTHER

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

Group A: conservative; Group B: probiotics

probiotics DIETARY_SUPPLEMENT

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

Group B: probiotics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Molise: lead

Study Sites (1)

University of Molise

Campobasso, Molise, 86100, Italy

Location

Related Publications (31)

• Gilchrist H, Lee G. Management of chalazia in general practice. Aust Fam Physician. 2009 May;38(5):311-4.

  PMID: 19458801 RESULT

• Unal M. Chalazion treatment. Orbit. 2008;27(6):397-8. doi: 10.1080/01676830802623174. No abstract available.

  PMID: 19085290 RESULT

• 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 RESULT

• Nemet AY, Vinker S, Kaiserman I. Associated morbidity of chalazia. Cornea. 2011 Dec;30(12):1376-81. doi: 10.1097/ICO.0b013e31821de36f.

  PMID: 21993469 RESULT

• 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 RESULT

• 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.

  PMID: 18412605 RESULT

• 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 RESULT

• 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.

  PMID: 31528769 RESULT

• 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.

  PMID: 25386597 RESULT

• 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 RESULT

• 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.

  PMID: 32238771 RESULT

• 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.

  PMID: 26963409 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 31125783 RESULT

• 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 RESULT

• 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.

  PMID: 21450914 RESULT

• 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.

  PMID: 14762403 RESULT

• 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.

  PMID: 30640553 RESULT

• 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.

  PMID: 29196767 RESULT

• 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.

  PMID: 28229218 RESULT

• 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 RESULT

• 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.

  PMID: 26370944 RESULT

• 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.

  PMID: 32169120 RESULT

• 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.

  PMID: 29435587 RESULT

• 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.

  PMID: 30545401 RESULT

• 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.

  PMID: 31644955 RESULT

• 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.

  PMID: 28892827 RESULT

Related Links

• MicroRNAs and microbiota: Is there a cross talk?

MeSH Terms

Conditions

Chalazion

Interventions

Conservative Treatment; Probiotics

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ciro Costagliola, Full Professor

  University of Molise

  PRINCIPAL INVESTIGATOR

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: April 8, 2020
• First Posted: April 13, 2020
• Study Start: February 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)