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.
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. Its main symptoms are dry skin and intense itching. There is currently no cure for eczema but there are treatments that try to relieve symptoms. These commonly include topical moisturisers and topical corticosteroids. Although topical corticosteroids are effective in minimising symptoms, there is a prevailing and universal fear of using topical corticosteroids which is one of the main reasons for poor treatment compliance. There have been emerging interests in prevention and treatment of eczema through modulation of the gut microbiome. The gut microbiome is a key regulator for the immune system and there is evidence that the composition of gut microbiome may reduce allergies by driving maturation of the immune system. It was shown that people with eczema have different bacteria in their gut compared to people without eczema. Therefore, this study's hypothesis is that administration of oral probiotics will benefit young children with eczema by improving their gut microbiome and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Probiotic
Placebo
Sydney Children's Hospital
Randwick, New South Wales, Australia
RECRUITINGProportion 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)
Time frame: Between baseline and 12 weeks
Mean change in SCORAD index
Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Scoring Atopic Dermatitis (SCORAD) index
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)