Probiotics for Chalaziosis Treatment in Children
Primary Purpose
Chalazion
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
probiotics
conservative treatment
Sponsored by
About this trial
This is an interventional supportive care trial for Chalazion focused on measuring microbiome/microbiota, probiotics, chalaziosis, children
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
Sites / Locations
- University of Molise
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group A: conservative
Group B: probiotics
Arm Description
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)
Outcomes
Primary Outcome Measures
Time Taken for a Complete Resolution of the Chalaziosis
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Number of Recurrences
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04322500
Brief Title
Probiotics for Chalaziosis Treatment in Children
Official Title
Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Molise
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion
Keywords
microbiome/microbiota, probiotics, chalaziosis, children
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective comparative pilot study with two groups randomly divided
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: conservative
Arm Type
Other
Arm Description
conservative treatment
Arm Title
Group B: probiotics
Arm Type
Experimental
Arm Description
in addition to the conservative treatment they receive a probiotics mixture (Streptococcus thermophilus ST10, Lactococcus lactis LLCO2 and Lactobacillus delbrueckii subsp. bulgaricus LDB01)
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conservative treatment
Intervention Description
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Primary Outcome Measure Information:
Title
Time Taken for a Complete Resolution of the Chalaziosis
Description
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Time Frame
3 months
Title
Number of Recurrences
Description
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)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ciro Costagliola, Full Professor
Organizational Affiliation
University of Molise
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Molise
City
Campobasso
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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29976412
Citation
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Links:
URL
http://fao.org/3/a-a0512e.pdf
Description
probiotics definition
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Probiotics for Chalaziosis Treatment in Children
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