Skip to main content
OpenTrials
Completed

NCT Number: NCT04322500

Probiotics for Chalaziosis Treatment in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chalazion Cysts Eye Diseases Eyelid Diseases Neoplasms

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Molise

Campobasso, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis

Conservative treatment

Other

lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days

Primary outcomes

  1. Time Taken for a Complete Resolution of the Chalaziosis

    Time frame: 3 months

    change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)

  2. Number of Recurrences

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Molise

Other

Registry information

Official study title

Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2020
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.