RecruitingPhase 2NCT06584552

LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)

Lactobacillus Paracasei LPB27 On Early Childhood Eczema

Sponsor

The University of New South Wales

Enrollment

100 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Allergy Eczema

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.

Eligibility

Min Age: 3 MonthsMax Age: 3 Years

Inclusion Criteria4

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 Criteria8

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and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).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.