Probiotics for Diaper Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OMNiBiOTiC® Panda, Placebo.
- Who it may be relevant to
- Registry conditions: Diaper Dermatitis. Basic parameters: 1 months — 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PROBIOTICS FOR TREATING DIAPER DERMATITIS IN CHILDREN - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL
Overview
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 supplement OMNiBiOTiC® Panda
Multistrain Probiotic OMNiBiOTiC® Panda containing: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactococcus lactis W58 and sunflower oil - Other Placebo
Placebo containing sunflower oil and maltodextrin
Primary outcome measures
- Duration of diaper dermatis [Time frame: 3 weeks supplementation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University of Maribor, Faculty of Health Sciences — Maribor
Identifiers
NCT: NCT06755307 · UKC-MB-KME-59/22