Probiotics for Diaper Dermatitis

NCT ID: NCT06755307

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-14

Study Completion Date

2026-03-01

Brief Summary

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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

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Conditions

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Diaper Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PROBIOTIC

Multistrain Probiotic OMNiBiOTiC® Panda containing probiotics and sunflower oil

Group Type EXPERIMENTAL

OMNiBiOTiC® Panda

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo containing sunflower oil and maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo containing sunflower oil and maltodextrin

Interventions

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OMNiBiOTiC® Panda

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo containing sunflower oil and maltodextrin

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Maribor

OTHER

Sponsor Role lead

Responsible Party

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Sabina Fijan

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maribor, Faculty of Health Sciences

Maribor, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Facility Contacts

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SABINA FIJAN, Ph.D

Role: primary

+386-230-4755

Other Identifiers

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UKC-MB-KME-59/22

Identifier Type: -

Identifier Source: org_study_id

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