LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)

Launched by THE UNIVERSITY OF NEW SOUTH WALES · Sep 2, 2024

Keywords

ClinConnect Summary

The LaCE study is a clinical trial that aims to find out if a special probiotic called Lactobacillus paracasei LPB27 can help treat eczema in young children. Eczema, also known as atopic dermatitis, is a common skin condition that causes redness, itching, and discomfort. This trial is designed for children aged between 3 months and 3 years old who have been diagnosed with mild to moderate eczema. To be eligible, children must have specific levels of eczema severity and must not be on certain medications or treatments that could interfere with the study.

If your child participates in this trial, they will be randomly assigned to receive either the probiotic or a placebo (a treatment that looks the same but has no active ingredients) for a set period. The study is not yet recruiting participants, so there’s no immediate action needed. It's important to note that if your child is breastfeeding, currently taking probiotics, or has certain skin or health conditions, they may not be eligible for this study. Overall, the LaCE trial hopes to provide more insights into how probiotics can support children with eczema.

Gender

ALL

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and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).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