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Completed

NCT Number: NCT04342507

Probiotics for Treatment of Chalazion in Adults

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.

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Key information

Conditions

Chalazion Cysts Eye Diseases Eyelid Diseases Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Molise

Campobasso, Molise, 86100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.)

Treatment and study plan

Conservative treatment

Other

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

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

Primary outcomes

  1. healing time

    Time frame: 3 months

    healing time changes with a complete resolution of chalazion

Secondary outcomes

  1. recurrences

    Time frame: six months

    evaluation of recurrences in both arms

Sponsors and collaborators

Lead sponsor

University of Molise

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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