LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
NCT Number: NCT06584552
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Eczema|Allergy
Interventions: DIETARY_SUPPLEMENT: Lactobacillus Paracasei LPB27|OTHER: Maltodextrin
Sponsor: The University of New South Wales
Collaborators: Evolution Health Pty Ltd
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09
Locations: Sydney Children's Hospital, Randwick, New South Wales, 2031, Australia|Sydney Children's Hospital, Sydney, New South Wales, 2038, Australia

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.

Primary Outcome Measures: Proportion of patients achieving treatment success, Clinically meaningful reduction (\>= 8.7 points) in SCORAD index between baseline and 12 weeks without the use of rescue medication (systemic immunosuppression and/or biologic agents), Between baseline and 12 weeks
Secondary Outcome Measures: Mean change in SCORAD index, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in SCORAD index, From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|First use of rescue medication, Time from baseline to first use of rescue medication, up to 12 weeks, From baseline to time of starting rescue medication (up to 12 weeks)|Mean change in RECAP, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Recap of Atopic Eczema (RECAP) score. The RECAP score ranges from a minimum of 0 to a maximum of 28, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in IDQOL, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Infant Dermatitis Quality of Life (IDQOL) score. The IDQOL score ranges from a minimum of 0 to a maximum of 30, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in EASI, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Eczema Area and Severity Index (EASI) score. The EASI score ranges from a minimum of 0 to a maximum of 72, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in IGA, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Investigator Global Assessment for Atopic Dermatitis (IGA) score. The IGA score ranges from a minimum of 0 to a maximum of 4, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in POEM, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Patient-Oriented Eczema Measure (POEM) score. The POEM score ranges from a minimum of 0 to a maximum of 28, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Use of topical corticosteroids, Mean weight (in grams) of topical corticosteroids used by participants during the 12 weeks of the study., From baseline to 12 weeks|Mean change in TOPICOP score, Mean change from baseline to 12 weeks in the Topical Corticosteroid Phobia (TOPICOP) score. The TOPICOP score ranges from a minimum of 0 to a maximum with 100, with higher scores indicating greater levels of phobia., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in gut microbiota, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in alpha diversity, beta diversity and short chain fatty avid levels measured from stool samples, From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in skin microbiota, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in alpha and beta diversity measured from skin swabs, From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)