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Clinical Trials/NCT06755307
NCT06755307
Recruiting
Not Applicable

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

University Maribor1 site in 1 country42 target enrollmentAugust 14, 2025
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ConditionsDiaper Dermatitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diaper Dermatitis
Sponsor
University Maribor
Enrollment
42
Locations
1
Primary Endpoint
Duration of diaper dermatis
Status
Recruiting
Last Updated
5 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.
Registry
clinicaltrials.gov
Start Date
August 14, 2025
End Date
March 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Maribor
Responsible Party
Principal Investigator
Principal Investigator

Sabina Fijan

Assoc. Prof. Dr.

University Maribor

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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