Probiotic treatment for diaper rash
PROBIOTICS FOR TREATING DIAPER DERMATITIS IN CHILDREN - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL
This tests whether the probiotic OMNiBiOTiC® Panda can shorten the duration of diaper rash in children under two years old.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 1 Month to 2 Years |
| Sex | All |
| Sponsor | University Maribor Academic / other |
| Locations | 1 site (Maribor) |
| Trial ID | NCT06755307 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled trial comparing daily OMNiBiOTiC® Panda droplets to a placebo in infants with diaper dermatitis. Caregivers will give six droplets per day for three weeks and record rash symptoms each day in a diary. The main outcome is the duration of the diaper dermatitis episode in the probiotic versus placebo groups. Children with recent probiotic use, acute bacterial infection, chronic disease, or local antibiotic use are excluded.
Who should consider this trial
Good fit: Infants younger than two years who currently have diaper dermatitis and do not have recent probiotic use, acute bacterial infection, chronic disease, or local antibiotic treatment are ideal candidates.
Not a fit: Children older than two years, those with chronic illnesses, acute bacterial infections, recent probiotic use, or current topical antibiotics in the anogenital area would not qualify and are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If effective, the probiotic could shorten diaper rash duration, reducing infant discomfort and the need for additional topical treatments.
How similar studies have performed: Previous probiotic research for infant skin conditions and related pediatric outcomes has shown mixed results, and probiotic treatment specifically for diaper dermatitis remains relatively limited and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Maribor
- University of Maribor, Faculty of Health Sciences — Maribor, Slovenia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.