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New treatment option for Eczema
Official title LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
ClinicalTrials.gov ID: NCT06584552
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 3
You may be able to join 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...
- Willingness and ability of the subject to comply with the protocol requirements.
You likely can't join if
- Patients on systemic immunosuppression and/or biologic agents (participants who start systemic immunosuppression and/or biologic agents mid-way...
- 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...
- 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...
- Immunodeficient disorders.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Randwick, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Randwick, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.