About this trial
The LaCE study is a double-blind, randomised, placebo-controlled trial examining the effectiveness of the probiotic Lactobacillus paracasei LPB27 in treating eczema in young children.
Eligibility criteria
Qualifiers
Age: 3 months to 3 years old
Diagnosis: Eczema (atopic dermatitis) diagnosed clinically by a paediatric dermatologist or immunologist.
Severity: Investigator Global Assessment for Atopic Dermatitis (IGA) severity of 1-3 (almost clear, mild, moderate) and a SCORAD score greater than 8.7.
Willingness and ability of the subject to comply with the protocol requirements.
Disqualifiers
Patients on systemic immunosuppression and/or biologic agents (participants who start systemic immunosuppression and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).
Mothers who are breastfeeding and on probiotics but not willing to stop probiotics.
Child already on probiotics and parents not willing to stop during the entire study period (washout period of 4 weeks; including formulas that contains probiotics).
Eczema complicated by active skin infection e.g. impetigo/cellulitis/ eczema herpeticum (can be considered once active infection resolved).
Trial design
Treatments tested in this trial
- Lactobacillus Paracasei LPB27
- Maltodextrin
Treatment groups
Sponsors and collaborators
The University of New South Wales
Lead sponsor
Evolution Health Pty Ltd
Collaborator