Lactobacillus paracasei LPB27 for early childhood eczema

Lactobacillus Paracasei LPB27 On Early Childhood Eczema

This trial tests whether giving the probiotic Lactobacillus paracasei LPB27 to children aged 3 months to 3 years with mild-to-moderate eczema can improve skin symptoms and quality of life compared with a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 3 Months to 3 Years
• Sex: All
• Sponsor: The University of New South Wales (Academic / other)
• Locations: 1 site (Randwick, New South Wales)
• Trial ID: NCT06584552 on ClinicalTrials.gov

What this trial studies

LaCE is a double-blind, randomized, placebo-controlled Phase 2 trial comparing oral Lactobacillus paracasei LPB27 versus a maltodextrin placebo in young children with eczema. Eligible participants are aged 3 months to 3 years with clinically diagnosed atopic dermatitis of mild to moderate severity (IGA 1-3) and a SCORAD score above 8.7. Key exclusions include current systemic immunosuppression or biologic therapy, ongoing probiotic use without an agreed washout, and active skin infection. Outcomes focus on changes in eczema severity and related quality-of-life measures over the treatment period.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 months to 3 years with mild-to-moderate atopic dermatitis (IGA 1-3 and SCORAD > 8.7) who are not on systemic immunosuppression and whose caregivers can comply with study procedures and probiotic washout requirements.

Not a fit: Children with severe eczema requiring systemic immunosuppression or biologics, those with active skin infection, or those who cannot stop concurrent probiotic use are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the probiotic could reduce eczema symptoms and improve quality of life for young children, potentially lowering reliance on topical corticosteroids.

How similar studies have performed: Prior trials of various probiotic strains in infants and children have shown inconsistent and often modest benefits for eczema, with effects depending strongly on the strain, timing, and study population.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Randwick, New South Wales

• Sydney Children's Hospital — Randwick, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Keith CY Ooi — University of New South Wales
• Study coordinator: Keith CY Ooi

Conditions Eczema; Allergy; Immunology; Microbiome; Paediatrics