Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
Location status: Recruiting
Location contact
Linda Martin
CONTACT
NCT Number: NCT06584552
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.
Interested in participating?
Request Info3 month–3 year
All sexes
Interventional
Phase 2
Randwick, New South Wales, 2031, Australia
Location status: Recruiting
Linda Martin
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotic
Placebo
Time frame: Between baseline and 12 weeks
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: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
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 time of starting rescue medication (up to 12 weeks)
Time from baseline to first use of rescue medication, up to 12 weeks
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
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 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 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.
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
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 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
Mean weight (in grams) of topical corticosteroids used by participants during the 12 weeks of the study.
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
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 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 from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in alpha and beta diversity measured from skin swabs
Contact information is provided by the study sponsor or research team.
The University of New South Wales
Other
Lactobacillus Paracasei LPB27 On Early Childhood Eczema
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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