LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)

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 Overview

• Status: Not yet recruiting
• Conditions: Allergy; Eczema
• Intervention / Treatment: Dietary supplement: Lactobacillus Paracasei LPB27; Other: Maltodextrin

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Keith CY Ooi; Phone Number: 02 9382 1752; Email: keith.ooi@unsw.edu.au
• Study Contact Backup: Name: Jessica Halim; Phone Number: 02 9382 1752; Email: lacestudy@unsw.edu.au

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Sydney Children's Hospital
      • Contact: Linda Martin
    • Sydney, New South Wales, Australia, 2038
      • Sydney Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus Paracasei LPB27; 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.	Dietary supplement: Lactobacillus Paracasei LPB27; Probiotic
Placebo Comparator: Maltodextrin; Formulation: Maltodextrin 1g Dosage: 1mg daily for 12 weeks. Delivered orally through through breast milk, formula or solid food.	Other: Maltodextrin; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Measures

Outcome Measure	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 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)

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: Evolution Health Pty Ltd
• Investigators: Principal Investigator: Keith CY Ooi, University of New South Wales

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome; Immunology; Paediatrics
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: 2024001_LaCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No