LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactobacillus Paracasei LPB27, Maltodextrin.
- Who it may be relevant to
- Registry conditions: Eczema, Allergy. Basic parameters: 3 months — 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lactobacillus Paracasei LPB27 On Early Childhood Eczema
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Lactobacillus Paracasei LPB27
Probiotic - Other Maltodextrin
Placebo
Primary outcome measures
- Proportion of patients achieving treatment success [Time frame: Between baseline and 12 weeks]
Secondary outcome measures (11)
- Mean change in SCORAD index [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- First use of rescue medication [Time frame: From baseline to time of starting rescue medication (up to 12 weeks)]
- Mean change in RECAP [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in IDQOL [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in EASI [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in IGA [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in POEM [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Use of topical corticosteroids [Time frame: From baseline to 12 weeks]
- Mean change in TOPICOP score [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in gut microbiota [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in skin microbiota [Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Sydney Children's Hospital — Randwick
Identifiers
NCT: NCT06584552 · 2024001_LaCE