Status:
RECRUITING
LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
Lead Sponsor:
The University of New South Wales
Collaborating Sponsors:
Evolution Health Pty Ltd
Conditions:
Eczema
Allergy
Eligibility:
All Genders
3-3 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Childhood eczema is a common and chronic, relapsing disease of the skin which affects up to 20% of the paediatric population. Eczema has significant impact on the quality of life of those affected. It...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).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).
- Child currently on oral or IV antibiotics (washout period of 4 weeks allowable once antibiotics completed). Participants who require antibiotics after being enrolled in the study may continue on the study as usual.
- Immunodeficient disorders.
- Chronic disorder involving the gastrointestinal tract (e.g., inflammatory bowel disease, short gut syndrome, cystic fibrosis).
- Known hypersensitivity to components contained in study product.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06584552
Start Date
November 15 2024
End Date
September 1 2026
Last Update
June 3 2025
Active Locations (1)
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1
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031