Trial Outcomes & Findings for Probiotics for Chalaziosis Treatment in Children (NCT NCT04322500)
NCT ID: NCT04322500
Last Updated: 2020-05-05
Results Overview
change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
3 months
Results posted on
2020-05-05
Participant Flow
Participant milestones
| Measure |
Group A: Conservative
conservative treatment
conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Probiotics for Chalaziosis Treatment in Children
Baseline characteristics by cohort
| Measure |
Group A: Conservative
n=13 Participants
conservative treatment
conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
|
Group B: Probiotics
n=13 Participants
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
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.9 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
8.6 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
8.3 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthschange in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)
Outcome measures
| Measure |
Group A: Conservative
n=13 Participants
conservative treatment
conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
|
Group B: Probiotics
n=13 Participants
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
|
|---|---|---|
|
Time Taken for a Complete Resolution of the Chalaziosis
|
51.2 days
Standard Deviation 12.4
|
28.4 days
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: 3 monthscomplete 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)
Outcome measures
| Measure |
Group A: Conservative
n=13 Participants
conservative treatment
conservative treatment: lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
|
Group B: Probiotics
n=13 Participants
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
|
|---|---|---|
|
Number of Recurrences
|
0 recurreces
|
0 recurreces
|
Adverse Events
Group A: Conservative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: Probiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Ciro Costagliola
University of Molise
Phone: +39 0874 404861/ 0874 404896
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place