Clinical trial NCT04322500: Probiotics for Chalaziosis Treatment in Children
Official title: Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chalazion
Keywords: microbiome/microbiota
probiotics
chalaziosis
children
Lead sponsor: University of Molise
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time Taken for a Complete Resolution of the Chalaziosis
timeFrame: 3 months
measure: Number of Recurrences
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: University of Molise
Study officials:
affiliation: University of Molise
name: Ciro Costagliola, Full Professor
role: PRINCIPAL_INVESTIGATOR
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