Health TrialsbyHealthPanel

LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)

ConditionsEczemaAllergy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-3
SponsorThe University of New South Wales

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactobacillus Paracasei LPB27

    Dietary supplement

    Probiotic

  • Maltodextrin

    Other intervention

    Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Lactobacillus Paracasei LPB27Experimental treatment 1 intervention
Group B: MaltodextrinPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
Between baseline and 12 weeks

Secondary outcomes

1

Mean change in SCORAD index

Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Scoring Atopic Dermatitis (SCORAD) index

Time frame
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
2

First use of rescue medication

Time from baseline to first use of rescue medication, up to 12 weeks

Time frame
From baseline to time of starting rescue medication (up to 12 weeks)
3

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.

Time frame
From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of New South Wales

Lead sponsor

Evolution Health Pty Ltd

Collaborator

Source ClinicalTrials.gov
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