Clinical trial NCT06584552: LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
Official title: Lactobacillus Paracasei LPB27 On Early Childhood Eczema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Eczema
Allergy
Keywords: Immunology
Microbiome
Paediatrics
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Evolution Health Pty Ltd
First posted: 2024-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Proportion of patients achieving treatment success
timeFrame: Between baseline and 12 weeks
Secondary outcomes:
measure: Mean change in SCORAD index
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: First use of rescue medication
timeFrame: From baseline to time of starting rescue medication (up to 12 weeks)
measure: Mean change in RECAP
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: Mean change in IDQOL
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: Mean change in EASI
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: Mean change in IGA
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: Mean change in POEM
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: Use of topical corticosteroids
timeFrame: From baseline to 12 weeks
measure: Mean change in TOPICOP score
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: Mean change in gut microbiota
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
measure: Mean change in skin microbiota
timeFrame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Keith CY Ooi
role: PRINCIPAL_INVESTIGATOR
References: