An interventional study of probiotics and conservative treatment in Chalazion, sponsored by University of Molise. Completed at 1 site in Italy. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by University of Molise · Not applicable, Interventional, and Supportive care
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.
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.
University of Molise is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
conservative treatment
Other: 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)
Dietary Supplement: probiotics · Other: conservative treatment
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
lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
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
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
| Milestone | Group A: Conservative | Group B: Probiotics |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 13 |
| Not completed | 0 | 0 |
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
| days | Group A: Conservative | Group B: Probiotics |
|---|---|---|
| Time Taken for a Complete Resolution of the Chalaziosis | 51.2 ± 12.4 | 28.4 ± 10.8 |
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)
| recurreces | Group A: Conservative | Group B: Probiotics |
|---|---|---|
| Number of Recurrences | 0 | 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: Conservative | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Group B: Probiotics | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Group A: Conservative | Group B: Probiotics | Total |
|---|---|---|---|
| Mean | 7.9 ± 1.2 | 8.6 ± 1.9 | 8.3 ± 1.5 |
| Sex: Female, Male(Participants) | Group A: Conservative | Group B: Probiotics | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 4 | 5 | 9 |
| Race (NIH/OMB)(Participants) | Group A: Conservative | Group B: Probiotics | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 13 | 13 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Group A: Conservative | Group B: Probiotics | Total |
|---|---|---|---|
| Italy | 13 | 13 | 26 |
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Chalazion
University of Molise