Probiotics for Diaper Dermatitis (ProDiaper II)

University Maribor

Status: Enrolling

Conditions: Diaper Dermatitis

Treatments: Dietary Supplement: OMNiBiOTiC® Panda; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06755307

UKC-MB-KME-59/22

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

PROBIOTIC

Experimental group

Description:

Multistrain Probiotic OMNiBiOTiC® Panda containing probiotics and sunflower oil

Treatment:

Dietary Supplement: OMNiBiOTiC® Panda

Placebo

Placebo Comparator group

Description:

Placebo containing sunflower oil and maltodextrin

Treatment:

Other: Placebo