Clinical trial NCT04342507: Probiotics for Treatment of Chalazion in Adults
Official title: Effects of Probiotic Oral Supplementation on the Treatment of Chalazion in Adults: a Pilot Study on 20 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chalazion
Keywords: microbiome/microbiota
probiotics
adults
Lead sponsor: University of Molise
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective comparative pilot study with two groups randomly divided
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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.)

Primary outcomes:
measure: healing time
timeFrame: 3 months
Secondary outcomes:
measure: recurrences
timeFrame: six months
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: University of Molise
state: Molise
Study officials:
affiliation: University of Molise
name: Ciro Costagliola, Full Professor
role: PRINCIPAL_INVESTIGATOR
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