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RecruitingNCT06755307ProDiaper IIUpdated Nov 24, 2025

Probiotics for Diaper Dermatitis

An interventional study of OMNiBiOTiC® Panda and Placebo in Diaper Dermatitis, sponsored by University Maribor. Recruiting at 1 site in Slovenia. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by University Maribor · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
1 Month to 2 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Diaper Dermatitis

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Keywords

  • diaper dermatitis
  • probiotics
  • children
03

In context

Diaper Rash

38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.

This study's planned enrollment of 42 is below the median of 92 across 28 interventional studies indexed under Diaper Rash.

Browse Diaper Rash studies →

Lead sponsor

University Maribor is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • presence of diaper dermatitis
  • age less than two years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    PROBIOTIC

    Multistrain Probiotic OMNiBiOTiC® Panda containing probiotics and sunflower oil

    Dietary Supplement: OMNiBiOTiC® Panda

  • Placebo comparator
    Placebo

    Placebo containing sunflower oil and maltodextrin

    Other: Placebo

Interventions

  • Dietary supplementOMNiBiOTiC® Panda

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

  • OtherPlacebo

    Placebo containing sunflower oil and maltodextrin

06

What researchers measure

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.

    Time frame: 3 weeks supplementation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06755307
Lead sponsor
University Maribor
Responsible party
Sabina Fijan (Assoc. Prof. Dr., University Maribor) — Principal investigator
First posted
Jan 1, 2025
Start date
Aug 14, 2025
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Nov 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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