NCT06755307

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

August 14, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

December 23, 2024

Last Update Submit

November 21, 2025

Conditions

Diaper Dermatitis

Keywords

diaper dermatitisprobioticschildren

Outcome Measures

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.

    3 weeks supplementation

Study Arms (2)

PROBIOTIC

EXPERIMENTAL

Multistrain Probiotic OMNiBiOTiC® Panda containing probiotics and sunflower oil

Dietary Supplement: OMNiBiOTiC® Panda

Placebo

PLACEBO COMPARATOR

Placebo containing sunflower oil and maltodextrin

Other: Placebo

Interventions

OMNiBiOTiC® PandaDIETARY_SUPPLEMENT

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

PROBIOTIC
PlaceboOTHER

Placebo containing sunflower oil and maltodextrin

Placebo

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • presence of diaper dermatitis
  • age less than two years

You may not qualify if:

  • previous use of probiotics
  • age more than two years
  • an acute bacterial infection
  • chronic disease
  • local use of antibiotics in the anogenital region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maribor, Faculty of Health Sciences

Maribor, 2000, Slovenia

RECRUITING

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 1, 2025

Study Start

August 14, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)