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Probiotics for Treatment of Chalazion in Adults

U

University of Molise

Status

Completed

Conditions

Chalazion

Treatments

Dietary Supplement: probiotics
Other: conservative treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04342507
08/2019

Details and patient eligibility

About

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.

Full 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).

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Group A: conservative
Other group
Description:
conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Treatment:
Other: conservative treatment
Group B: probiotics
Experimental group
Description:
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.
Treatment:
Other: conservative treatment
Dietary Supplement: probiotics

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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