LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)

NCT06584552 | Recruiting Phase 2 DMC

• 1 other identifier: 2024001_LaCE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema; Allergy

Keywords

Immunology; Microbiome; Paediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Mean change in SCORAD index

  From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)

• First use of rescue medication

  From baseline to time of starting rescue medication (up to 12 weeks)

• Mean change in RECAP

  From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)

• Mean change in IDQOL

  From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)

• Mean change in EASI

  From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)

Study Arms (2)

Lactobacillus Paracasei LPB27

EXPERIMENTAL

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

Maltodextrin

PLACEBO COMPARATOR

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

Other: Maltodextrin

Interventions

Lactobacillus Paracasei LPB27 DIETARY_SUPPLEMENT

Probiotic

Lactobacillus Paracasei LPB27

Maltodextrin OTHER

Placebo

Maltodextrin

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of New South Wales: lead
• Evolution Health Pty Ltd: collaborator

Study Sites (1)

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

MeSH Terms

Conditions

Eczema; Hypersensitivity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Immune System Diseases

Study Officials

• Keith CY Ooi

  University of New South Wales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith CY Ooi

CONTACT

9382 1752; keith.ooi@unsw.edu.au

Jessica Halim

CONTACT

9382 1752; lacestudy_SCH@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 5, 2024
• Study Start: November 15, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)