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NCT Number: NCT06584552

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.

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Key information

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location status: Recruiting

Location contact

Linda Martin

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus Paracasei LPB27

Dietary Supplement

Probiotic

maltodextrin

Other

Placebo

Primary outcomes

  1. Proportion of patients achieving treatment success

    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)

Secondary outcomes

  1. Mean change in SCORAD index

    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

  2. First use of rescue medication

    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

  3. Mean change in RECAP

    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.

  4. Mean change in IDQOL

    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.

  5. Mean change in EASI

    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.

  6. Mean change in IGA

    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.

  7. Mean change in POEM

    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.

  8. Use of topical corticosteroids

    Time frame: From baseline to 12 weeks

    Mean weight (in grams) of topical corticosteroids used by participants during the 12 weeks of the study.

  9. Mean change in TOPICOP score

    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.

  10. Mean change in gut microbiota

    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

  11. Mean change in skin microbiota

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Halim

CONTACT

[email protected]

9382 1752 ext. 02

Keith CY Ooi

CONTACT

[email protected]

9382 1752 ext. 02

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • Evolution Health Pty Ltd

Registry information

Official study title

Lactobacillus Paracasei LPB27 On Early Childhood Eczema

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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