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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06584552




Registration number
NCT06584552
Ethics application status
Date submitted
21/08/2024
Date registered
5/09/2024

Titles & IDs
Public title
LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
Scientific title
Lactobacillus Paracasei LPB27 On Early Childhood Eczema
Secondary ID [1] 0 0
2024001_LaCE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 0 0
Allergy 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Lactobacillus Paracasei LPB27
Other interventions - Maltodextrin

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.

Placebo comparator: Maltodextrin - Formulation: Maltodextrin 1g

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


Treatment: Other: Lactobacillus Paracasei LPB27
Probiotic

Other interventions: Maltodextrin
Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients achieving treatment success
Timepoint [1] 0 0
Between baseline and 12 weeks
Secondary outcome [1] 0 0
Mean change in SCORAD index
Timepoint [1] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [2] 0 0
First use of rescue medication
Timepoint [2] 0 0
From baseline to time of starting rescue medication (up to 12 weeks)
Secondary outcome [3] 0 0
Mean change in RECAP
Timepoint [3] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [4] 0 0
Mean change in IDQOL
Timepoint [4] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [5] 0 0
Mean change in EASI
Timepoint [5] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [6] 0 0
Mean change in IGA
Timepoint [6] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [7] 0 0
Mean change in POEM
Timepoint [7] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [8] 0 0
Use of topical corticosteroids
Timepoint [8] 0 0
From baseline to 12 weeks
Secondary outcome [9] 0 0
Mean change in TOPICOP score
Timepoint [9] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [10] 0 0
Mean change in gut microbiota
Timepoint [10] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Secondary outcome [11] 0 0
Mean change in skin microbiota
Timepoint [11] 0 0
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)

Eligibility
Key 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.
Minimum age
3 Months
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2038 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Evolution Health Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith CY Ooi
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Keith CY Ooi
Address 0 0
Country 0 0
Phone 0 0
9382 1752
Fax 0 0
Email 0 0
keith.ooi@unsw.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06584552