EczemaPhase 2NCT06584552
LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
A Phase 2 study testing Lactobacillus Paracasei LPB27 and Maltodextrin in people with Eczema and Allergy, run by The University of New South Wales at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- What is being tested?
- Lactobacillus Paracasei LPB27 and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Nov 2024to Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Sydney Children's Hospital
Randwick, New South Wales, 2031
Linda Martin
About this study
Official title: Lactobacillus Paracasei LPB27 On Early Childhood Eczema
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.
Read the detailed description
Childhood eczema is a common and chronic, relapsing disease of the skin which affects up to 20% of the paediatric population. Eczema has significant impact on the quality of life of those affected. Its main symptoms are dry skin and intense itching.
There is currently no cure for eczema but there are treatments that try to relieve symptoms. These commonly include topical moisturisers and topical corticosteroids.
Although topical corticosteroids are effective in minimising symptoms, there is a prevailing and universal fear of using topical corticosteroids which is one of the main reasons for poor treatment compliance.
There have been emerging interests in prevention and treatment of eczema through modulation of the gut microbiome. The gut microbiome is a key regulator for the immune system and there is evidence that the composition of gut microbiome may reduce allergies by driving maturation of the immune system. It was shown that people with eczema have different bacteria in their gut compared to people without eczema. Therefore, this study's hypothesis is that administration of oral probiotics will benefit young children with eczema by improving their gut microbiome and quality of life.
- Being tested
- Lactobacillus Paracasei LPB27, Maltodextrin
- Keywords
- Immunology, Microbiome, Paediatrics
- Medical subject headings
- Eczema, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Paracasei LPB27Dietary supplement
Probiotic
MaltodextrinOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus Paracasei LPB27 | Experimental | 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. Receives: Dietary Supplement: Lactobacillus Paracasei LPB27 |
| Maltodextrin | Placebo comparator | Formulation: Maltodextrin 1g
Dosage: 1mg daily for 12 weeks. Delivered orally through through breast milk, formula or solid food. Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Between baseline and 12 weeks
Secondary outcomes (11)
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
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
First use of rescue medication
Time from baseline to first use of rescue medication, up to 12 weeks
Measured: From baseline to time of starting rescue medication (up to 12 weeks)
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.
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
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.
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in EASI
Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Eczema Area and Severity Index (EASI) score. The EASI score ranges from a minimum of 0 to a maximum of 72, with higher scores indicating worse outcomes.
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in IGA
Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Investigator Global Assessment for Atopic Dermatitis (IGA) score. The IGA score ranges from a minimum of 0 to a maximum of 4, with higher scores indicating worse outcomes.
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in POEM
Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Patient-Oriented Eczema Measure (POEM) score. The POEM score ranges from a minimum of 0 to a maximum of 28, with higher scores indicating worse outcomes.
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Use of topical corticosteroids
Mean weight (in grams) of topical corticosteroids used by participants during the 12 weeks of the study.
Measured: From baseline to 12 weeks
Mean change in TOPICOP score
Mean change from baseline to 12 weeks in the Topical Corticosteroid Phobia (TOPICOP) score. The TOPICOP score ranges from a minimum of 0 to a maximum with 100, with higher scores indicating greater levels of phobia.
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in gut microbiota
Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in alpha diversity, beta diversity and short chain fatty avid levels measured from stool samples
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in skin microbiota
Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in alpha and beta diversity measured from skin swabs
Measured: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start15 Nov 2024
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Evolution Health Pty Ltd
- Responsible party
- Principal investigator, Keith Chee Y. Ooi, The University of New South Wales
- Investigators
- Keith CY Ooi, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584552
- Sponsor's protocol ID
- 2024001_LaCE
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Paracasei LPB27 On Early Childhood Eczema
- ClinicalTrials.gov ID
- NCT06584552
- Acronym / sponsor ID
- 2024001_LaCE
- Keywords
- Immunology, Microbiome, Paediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Evolution Health Pty Ltd
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood eczema is a common and chronic, relapsing disease of the skin which affects up to 20% of the paediatric population. Eczema has significant impact on the quality of life of those affected. Its main symptoms are dry skin and intense itching.
There is currently no cure for eczema but there are treatments that try to relieve symptoms. These commonly include topical moisturisers and topical corticosteroids.
Although topical corticosteroids are effective in minimising symptoms, there is a prevailing and universal fear of using topical corticosteroids which is one of the main reasons for poor treatment compliance.
There have been emerging interests in prevention and treatment of eczema through modulation of the gut microbiome. The gut microbiome is a key regulator for the immune system and there is evidence that the composition of gut microbiome may reduce allergies by driving maturation of the immune system. It was shown that people with eczema have different bacteria in their gut compared to people without eczema. Therefore, this study's hypothesis is that administration of oral probiotics will benefit young children with eczema by improving their gut microbiome and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus Paracasei LPB27 | Experimental | Dietary Supplement: Lactobacillus Paracasei LPB27Formulation: 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. |
| Maltodextrin | Placebo comparator | Other: MaltodextrinFormulation: Maltodextrin 1g Dosage: 1mg daily for 12 weeks. Delivered orally through through breast milk, formula or solid food. |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus Paracasei LPB27Probiotic | Dietary supplement | Lactobacillus Paracasei LPB27 |
| MaltodextrinPlacebo | Other | Maltodextrin |
Primary outcome
Proportion of patients achieving treatment success
Time frame: Between baseline and 12 weeks
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)
11 secondary outcomes
Mean change in SCORAD index
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
First use of rescue medication
Time frame: From baseline to time of starting rescue medication (up to 12 weeks)
Mean change in RECAP
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in IDQOL
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in EASI
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in IGA
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in POEM
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Use of topical corticosteroids
Time frame: From baseline to 12 weeks
Mean change in TOPICOP score
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in gut microbiota
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Mean change in skin microbiota
Time frame: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith CY Ooi principal investigator
University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus Paracasei LPB27 and Maltodextrin in people with Eczema and Allergy, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith CY Ooi (9382 1752 ext. 02, keith.ooi@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving treatment success (time frame: Between baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.