Probiotics for Chalaziosis Treatment in Children

Not Applicable

Completed

• Conditions: Chalazion
• Interventions: Dietary Supplement: probiotics; Other: conservative treatment

• Registration Number: NCT04322500
• Lead Sponsor: University of Molise

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Status Verified: 2020-04
• Results First Submitted: 2020-04-02
• Results First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-23
• Results First Posted: 2020-04-24
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time Taken for a Complete Resolution of the Chalaziosis	3 months	change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Number of Recurrences	3 months	complete ophthalmological evaluation was done weekly during the first month and then monthly in order to evaluate possible recurrences (presence of a new eyelid mass lesion)

Trial Locations

Locations (1)

University of Molise; 🇮🇹 Campobasso, Italy