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

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT07072273
• Lead Sponsor: Biogaia New Sciences AB

Brief Summary

The goal of this study is to evaluate the efficacy of the emollient topical formulation containing Lactobacillus reuteri BGR46 in improving atopic dermatitis symptoms in children.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-10-01
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in SCORAD after 8 weeks	8 weeks	Change in SCORAD index from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri BGR46.

Secondary Outcome Measures

Name	Time	Method
Change in SCORAD after 1 week	1 week	Change in SCORAD index from baseline after 1 week of treatment with the topical emollient formulation containing Lactobacillus reuteri BGR46.
Change in SCORAD after 4 weeks	4 weeks	Change in SCORAD index from baseline after 4 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri BGR46.
Change in POEM	1, 4 and 8 weeks	Change in POEM score from baseline after 1, 4, and 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri BGR46.
Change in PIQoL-AD	8 weeks	Change in PIQoL-AD score from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri BGR46.