LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT06584552
Intervention or treatment
DIETARY_SUPPLEMENT: Lactobacillus Paracasei LPB27
OTHER: Maltodextrin
Conditions
- Eczema
- Allergy
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Sydney Children's Hospital
Select from list below to view details:
Sydney Children's Hospital
Randwick, New South Wales, Australia
Loading map...
Who is running the clinical trial?
The University of New South Wales
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Lactobacillus Paracasei LPB27
| Dietary Supplement: Lactobacillus Paracasei LPB27 |
PLACEBO_COMPARATOR: Maltodextrin
| Other: Maltodextrin |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
References
Clinical Trials Gov: LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)Other trials to consider
Loading suggested trials...
