Diaper Dermatitis
Conditions
Keywords
diaper dermatitis, probiotics, children
Brief summary
The goal of this randomized controlled clinical trial is to determine the effect of the probiotic OMNiBiOTiC® Panda in treating diaper dermatitis in children under the age of two years. The main question it aims to answer is: Is the probiotic OMNiBiOTiC® Panda effective in reducing the duration of diaper dermatitis in children under the age of two years? Researchers will compare the probiotic and placebo group to see if the duration of diaper dermatitis is significant among the two groups. Participants will: * receive 6 droplets daily of probiotic or placebo for 3 weeks and * observe and record improvement of diaper rash symptoms each day using a diary.
Interventions
DIETARY_SUPPLEMENTOMNiBiOTiC® Panda
Multistrain Probiotic OMNiBiOTiC® Panda containing: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactococcus lactis W58 and sunflower oil
OTHERPlacebo
Placebo containing sunflower oil and maltodextrin
Sponsors
University Maribor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* presence of diaper dermatitis * age less than two years
Exclusion criteria
* previous use of probiotics * age more than two years * an acute bacterial infection * chronic disease * local use of antibiotics in the anogenital region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diaper dermatis | 3 weeks supplementation | Comparison of the duration of diaper dermatitis in children younger than two years in both arms via daily the use of the diary. |
Countries
Slovenia
Outcome results
None listed