Probiotics for Diaper Dermatitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-2
SponsorUniversity Maribor

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

presence of diaper dermatitis

age less than two years

Disqualifiers

previous use of probiotics

age more than two years

an acute bacterial infection

chronic disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • OMNiBiOTiC® Panda

    Dietary supplement

    Multistrain Probiotic OMNiBiOTiC® Panda containing: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactococcus lactis W58 and sunflower oil

  • Placebo

    Other intervention

    Placebo containing sunflower oil and maltodextrin

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: PROBIOTICExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of diaper dermatis

Comparison of the duration of diaper dermatitis in children younger than two years in both arms via daily the use of the diary.

Time frame
3 weeks supplementation

Secondary outcomes

Other outcomes

Sponsors and contacts

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