Probiotics for Chalaziosis Treatment in Children

University of Molise

Status: Completed

Conditions: Chalazion

Treatments: Other: conservative treatment; Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04322500

07/2019

Details and patient eligibility

About

There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.

Full description

Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results.

Enrollment: 26 patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• paediatric patients
• presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months)

Exclusion criteria

• eyelid infection
• chalazion duration < 1 month
• nonpalpable chalazion
• suspicion of malignancy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

Group A: conservative

Other group

Description:

conservative treatment

Treatment:

Other: conservative treatment

Group B: probiotics

Experimental group

Description:

in addition to the conservative treatment they receive a probiotics mixture (Streptococcus thermophilus ST10, Lactococcus lactis LLCO2 and Lactobacillus delbrueckii subsp. bulgaricus LDB01)

Treatment:

Dietary Supplement: probiotics

Other: conservative treatment