Probiotics for Chalaziosis Treatment in Children

Brief Title

Probiotics for Chalaziosis Treatment in Children

Official Title

Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children

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 Type

Interventional


Primary Outcome

Time Taken for a Complete Resolution of the Chalaziosis


Condition

Chalazion

Intervention

probiotics

Study Arms / Comparison Groups

 Group A: conservative
Description:  conservative treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

26

Start Date

February 1, 2019

Completion Date

February 29, 2020

Primary Completion Date

February 29, 2020

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
      

Gender

All

Ages

3 Years - 14 Years

Accepts Healthy Volunteers

No

Contacts

Ciro Costagliola, Full Professor, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04322500

Organization ID

07/2019


Responsible Party

Principal Investigator

Study Sponsor

University of Molise


Study Sponsor

Ciro Costagliola, Full Professor, Principal Investigator, University of Molise


Verification Date

April 2020