NCT06584552 LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
| NCT ID | NCT06584552 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of New South Wales |
| Condition | Eczema |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-11-15 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).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.
Contact & Investigator
Keith CY Ooi
PRINCIPAL INVESTIGATOR
University of New South Wales
Frequently Asked Questions
Who can join the NCT06584552 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 3 Years, studying Eczema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06584552 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06584552 currently recruiting?
Yes, NCT06584552 is actively recruiting participants. Contact the research team at keith.ooi@unsw.edu.au for enrollment information.
Where is the NCT06584552 trial being conducted?
This trial is being conducted at Randwick, Australia.
Who is sponsoring the NCT06584552 clinical trial?
NCT06584552 is sponsored by The University of New South Wales. The principal investigator is Keith CY Ooi at University of New South Wales. The trial plans to enroll 100 participants.
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