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NCT Number: NCT06755307

Probiotics for Diaper Dermatitis

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.

Recruiting

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Key information

Conditions

Diaper Dermatitis Dermatitis Dermatitis, Contact Dermatitis, Irritant Diaper Rash Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maribor, Faculty of Health Sciences

Maribor, 2000, Slovenia

Location status: Recruiting

Location contact

SABINA FIJAN, Ph.D

CONTACT

[email protected]

+386-230-4755

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo containing sunflower oil and maltodextrin

Primary outcomes

  1. Duration of diaper dermatis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Maribor

Other

Registry information

Official study title

PROBIOTICS FOR TREATING DIAPER DERMATITIS IN CHILDREN - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL

Acronym: ProDiaper II

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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