Probiotics for Diaper Dermatitis

Not Applicable

Not yet recruiting

• Conditions: Diaper Dermatitis

• Registration Number: NCT06755307
• Lead Sponsor: University Maribor

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Study Start: 2025-01-15
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Maribor, Faculty of Health Sciences; 🇸🇮 Maribor, Slovenia