LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)

The University of New South Wales

Status and phase: Not yet enrolling; Phase 2

Conditions: Eczema; Allergy

Treatments: Other: Maltodextrin; Dietary Supplement: Lactobacillus Paracasei LPB27

Study type: Interventional

Funder types: Other

Identifiers

NCT06584552

2024001_LaCE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 months to 3 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Lactobacillus Paracasei LPB27

Experimental group

Description:

Formulation: Lactobacillus paracasei LPB27 (10 billion cfu/ serve) and Maltodextrin (up to 1g). Dosage: 1mg daily for 12 weeks. Delivered orally through through breast milk, formula or solid food.

Treatment:

Dietary Supplement: Lactobacillus Paracasei LPB27

Maltodextrin

Placebo Comparator group

Description:

Formulation: Maltodextrin 1g Dosage: 1mg daily for 12 weeks. Delivered orally through through breast milk, formula or solid food.

Treatment:

Other: Maltodextrin