Actively Recruiting
Lactobacillus Paracasei LPB27 On Early Childhood Eczema
Led by The University of New South Wales · Updated on 2025-06-03
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
T
The University of New South Wales
Lead Sponsor
E
Evolution Health Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of the probiotic Lactobacillus paracasei LPB27 in treating eczema in young children aged 3 months to 3 years. Childhood eczema is a common, chronic skin condition causing dry skin and itching, which significantly affects quality of life. The study explores whether oral probiotics can improve gut microbiome composition and thereby benefit eczema symptoms and overall well-being. Participants will receive either Lactobacillus paracasei LPB27 at a dose of 10 billion colony-forming units per day or a placebo containing maltodextrin. Both treatments are administered orally once daily for 12 weeks, mixed with breast milk, formula, or solid food. The trial is randomized, double-blind, and placebo-controlled to compare the probiotic against the placebo effectively. During the 12-week study, children will be monitored for treatment success based on symptom improvement. Researchers will assess changes in eczema severity using various validated scores, track the use of rescue medications, and evaluate changes in gut and skin microbiota. Safety and adherence will be observed throughout the study, with the main outcome measured at 12 weeks after starting treatment.
CONDITIONS
Brief Title
LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 months and 3 years old
- Clinical diagnosis of eczema by a paediatric dermatologist or immunologist
- Eczema severity rated as almost clear, mild, or moderate by Investigator Global Assessment (IGA)
- SCORAD score greater than 8.7
- Willingness and ability to comply with study requirements
You will not qualify if you...
- Use of systemic immunosuppressive or biologic medications
- Mothers breastfeeding and taking probiotics who do not wish to stop
- Child currently on probiotics and parents unwilling to stop during the study (including probiotic-containing formulas) without a 4-week washout
- Active skin infection complicating eczema (e.g., impetigo, cellulitis, eczema herpeticum) unless resolved
- Current use of oral or intravenous antibiotics (unless completed with 4-week washout)
- Immunodeficient disorders
- Chronic gastrointestinal disorders such as inflammatory bowel disease, short gut syndrome, or cystic fibrosis
- Known allergy to any components of the study product
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive daily oral probiotic or placebo for 12 weeks to evaluate effects on eczema symptoms and gut microbiome.
Visits as needed for medication dispensing and symptom assessments
Trial Site Locations
Total: 1 location
1
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Research Team
K
Keith CY Ooi
J
Jessica Halim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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