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ChalazionNCT04342507

Probiotics for Treatment of Chalazion in Adults

A study testing conservative treatment and probiotics in people with Chalazion, run by University of Molise at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chalazion
What is being tested?
conservative treatment and probiotics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Feb 2019to 29 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Molise

    Campobasso, Molise, 86100

Other trials in Italy

About this study

Official title: Effects of Probiotic Oral Supplementation on the Treatment of Chalazion in Adults: a Pilot Study on 20 Patients

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.

Read the detailed description

Prospective comparative pilot study on 20 adults suffering from chalazion randomly divided into two groups. The first group, received conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days. The second group, in addition to the conservative treatment, received a mixture of probiotic microorganisms once a day up to 3 months. Chalazia were classified according to their size into three groups: small (≤2 mm), medium (2-4 mm), or large (>4 mm). When conservative treatment (with and without probiotics supplementation) failed to resolve the lesion, invasive methods were used, (intralesion steroid injection in medium size chalazion and surgical incision and curettage for the largest ones).

Conditions
Chalazion
Being tested
conservative treatment, probiotics
Keywords
microbiome/microbiota, probiotics, adults
Medical subject headings
Chalazion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conservative treatmentOther

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

  • probioticsDietary 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

Study groups in NCT04342507
Study groupRoleWhat they receive
Group A: conservativeOtherconservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Receives: Other: conservative treatment
Group B: probioticsExperimentalin addition to the conservative treatment they receive probiotics mixture (Streptococcus thermophilus, Lactococcus lactis, Lactobacillus delbrueckii subsp. bulgaricus) once a day up to 3 months.
Receives: Other: conservative treatment; Dietary Supplement: probiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. healing time

    healing time changes with a complete resolution of chalazion

    Measured: 3 months

Secondary outcomes (1)

  1. recurrences

    evaluation of recurrences in both arms

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start1 Feb 2019
  3. Primary completion29 Feb 2020
  4. Study completion29 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective comparative pilot study with two groups randomly divided
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04342507
Sponsor's protocol ID
08/2019
Status last verified
Apr 2020
First submitted
8 Apr 2020
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 19458801

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

    PubMed 19085290

  • 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.

    PubMed 31088416

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

    PubMed 21993469

  • 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.

    PubMed 23873491

  • 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.

    PubMed 18412605

  • 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.

    PubMed 29392144

  • 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.

    PubMed 31528769

  • 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.

    PubMed 25386597

  • 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.

    PubMed 29976412

  • 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.

    PubMed 32238771

  • 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.

    PubMed 26963409

  • 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.

    PubMed 30262956

  • 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.

    PubMed 18040708

  • 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.

    PubMed 31262073

Questions about this trial

What is this clinical trial studying?

A study testing conservative treatment and probiotics in people with Chalazion, run by University of Molise at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

healing time (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342507, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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