Chalazion
Conditions
Keywords
microbiome/microbiota, probiotics, chalaziosis, 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.
Interventions
DIETARY_SUPPLEMENTprobiotics
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
OTHERconservative treatment
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Sponsors
University of Molise
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective comparative pilot study with two groups randomly divided
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A: Conservative conservative treatment
conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days | 13 |
| Group B: Probiotics in addition to the conservative treatment they receive a probiotics mixture (ST10, LLCO2 and LDB01)
probiotics: 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: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Group A: Conservative | Total | Group B: Probiotics |
|---|---|---|---|
| Age, Continuous | 7.9 years STANDARD_DEVIATION 1.2 | 8.3 years STANDARD_DEVIATION 1.5 | 8.6 years STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 26 Participants | 13 Participants |
| Region of Enrollment Italy | 13 participants | 26 participants | 13 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
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)
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: Conservative | Number of Recurrences | 0 recurreces |
| Group B: Probiotics | Number of Recurrences | 0 recurreces |
Primary
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)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Conservative | Time Taken for a Complete Resolution of the Chalaziosis | 51.2 days | Standard Deviation 12.4 |
| Group B: Probiotics | Time Taken for a Complete Resolution of the Chalaziosis | 28.4 days | Standard Deviation 10.8 |