Diaper DermatitisProDiaper IINCT06755307
Probiotics for Diaper Dermatitis
A study testing OMNiBiOTiC® Panda in people with Diaper Dermatitis, run by University Maribor at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Diaper Dermatitis
- What is being tested?
- OMNiBiOTiC® Panda
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSlovenia
- Study dates
- 14 Aug 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- presence of diaper dermatitis
- age less than two years
Who cannot join
- previous use of probiotics
- age more than two years
- an acute bacterial infection
- chronic disease
- local use of antibiotics in the anogenital region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University of Maribor, Faculty of Health Sciences
Maribor, 2000
SABINA FIJAN, Ph.D, +386-230-4755, sabina.fijan@um.si
About this study
Official title: PROBIOTICS FOR TREATING DIAPER DERMATITIS IN CHILDREN - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL
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.
- Conditions
- Diaper Dermatitis
- Being tested
- OMNiBiOTiC® Panda, Placebo
- Keywords
- diaper dermatitis, probiotics, children
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNiBiOTiC® PandaDietary supplement
Multistrain Probiotic OMNiBiOTiC® Panda containing: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactococcus lactis W58 and sunflower oil
PlaceboOther
Placebo containing sunflower oil and maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| PROBIOTIC | Experimental | Multistrain Probiotic OMNiBiOTiC® Panda containing probiotics and sunflower oil Receives: Dietary Supplement: OMNiBiOTiC® Panda |
| Placebo | Placebo comparator | Placebo containing sunflower oil and maltodextrin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start14 Aug 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabina Fijan, University Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755307
- Sponsor's protocol ID
- UKC-MB-KME-59/22
- Acronym
- ProDiaper II
- Status last verified
- Nov 2025
- First submitted
- 23 Dec 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROBIOTICS FOR TREATING DIAPER DERMATITIS IN CHILDREN - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06755307
- Acronym / sponsor ID
- ProDiaper II / UKC-MB-KME-59/22
- Conditions
- Diaper Dermatitis
- Keywords
- diaper dermatitis, probiotics, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University MariborUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROBIOTIC | Experimental | Dietary Supplement: OMNiBiOTiC® PandaMultistrain Probiotic OMNiBiOTiC® Panda containing probiotics and sunflower oil |
| Placebo | Placebo comparator | Other: PlaceboPlacebo containing sunflower oil and maltodextrin |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- presence of diaper dermatitis
- age less than two years
Key exclusion criteria (5 listed)
- previous use of probiotics
- age more than two years
- an acute bacterial infection
- chronic disease
- local use of antibiotics in the anogenital region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNiBiOTiC® PandaMultistrain Probiotic OMNiBiOTiC® Panda containing: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactococcus lactis W58 and sunflower oil | Dietary supplement | PROBIOTIC |
| PlaceboPlacebo containing sunflower oil and maltodextrin | Other | Placebo |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Diaper Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNiBiOTiC® Panda in people with Diaper Dermatitis, run by University Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of diaper dermatis (time frame: 3 weeks supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.