A Clinical Trial Evaluating a Probiotic Emollient for the Treatment of Pediatric Atopic Dermatitis

Launched by BIOGAIA NEW SCIENCES AB · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new skin treatment that contains a helpful type of probiotic called Lactobacillus reuteri BGR46 to see if it can improve symptoms of atopic dermatitis (also known as eczema) in children. Atopic dermatitis causes dry, itchy, and inflamed skin, and this study aims to find out if this probiotic cream can help reduce those symptoms.

Children between 6 months and 12 years old who have been diagnosed with moderate eczema (based on a specific scoring system) may be eligible to participate. Before joining, parents or guardians must give their permission. Some children won’t be able to join if they have recently used certain medications like steroids, antibiotics, or probiotics, or if they have other health conditions that could affect the results. If eligible, participants will apply the probiotic cream to their skin, and researchers will monitor their progress to see how well the treatment works. This study is not yet recruiting, so families interested in joining should stay tuned for updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pediatric patients of both sexes, aged between 6 months and 12 years, with a confirmed diagnosis of AD based on Hanifin and Rajka criteria (ANNEX VIII).
• • SCORAD index between 20 and 50, inclusive.
• • Signed informed consent by parents or legal guardians.
• Exclusion Criteria:
• • History of phototherapy for the treatment of AD.
• • Previous treatment with biologic agents or JAK inhibitors for AD.
• • Use of systemic corticosteroids within one month prior to inclusion in the clinical trial.
• • Use of topical corticosteroids within one month prior to inclusion in the clinical trial.
• • Use of conventional systemic immunosuppressants for AD (e.g., azathioprine, methotrexate, or cyclosporine) within three months prior to inclusion in the clinical trial.
• • Use of oral or topical probiotics within two months prior to inclusion in the clinical trial.
• • Use of topical or systemic antibiotics within one month prior to inclusion in the clinical trial.
• • Known hypersensitivity to the investigational product or any of its components.
• • Underlying immune-mediated diseases requiring systemic corticosteroid therapy.
• • Active infection in areas affected by AD requiring antibiotic, antifungal, or antiviral treatment within the one month prior to inclusion in the clinical trial.
• • Fever at the start of treatment (axillary temperature \>37.5 °C or equivalent).
• • Diagnosed immunodeficiency disorders.
• • Current or past diagnosis of malignant neoplasms.
• • Any concurrent dermatologic or medical condition that, in the investigator's opinion, could interfere with the subject's response to treatment or require continuous use of topical corticosteroids.
• • Participation in other clinical research studies involving investigational products within one month prior to inclusion in the clinical trial.