Atopic Dermatitis
Conditions
Keywords
Skin microbiome, Probiotics, Lactobacillus spp.
Brief summary
The skin microbiome of atopic dermatitis patients and healthy volunteers will be studies by collecting and analysing skin swabs on different timepoint. Additional, effort will be made to isolate and characterize Lactobacillus spp. and other beneficial micro-organisms on the skin. Second aim of this study is to evaluate a topical probiotic cream in atopic dermatitis treatment. A double-blind placebo-controlled intervention study will be performed in parallel with the skin microbiome analysis. Both clinical effect on the symptoms of atopic dermatitis and effect on the skin microbiome and survival of beneficial bacteria on the skin will be evaluated.
Detailed description
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in atopic dermatitis (AD). The etiology of AD is complex, with the manifestation of the disease being influenced by various genetic and immune mechanisms acting in concert with environmental factors. A reduction in the skin microbial diversity is often observed and flares are characterized by an abundance of skin pathobionts such as Staphylococcus aureus. Therefore, topical probiotic strains could have a positive effect on the skin microbiome and function by inhibiting pathogens, restoring the skin microbiome and/or barrier function and executing anti-inflammatory effects on the skin cells. The main objectives of this study are to analyse the skin microbiome in healthy volunteers and patients AD to obtain in depth data of the composition of the skin microbiome and identify possible biomarkers for AD. In parallel, a double-blind placebo-controlled study with topically applied live lactobacilli will be performed to give more insights in the working mechanisms of lactobacilli on AD skin. More specifically to evaluate the effect of the 'live' Lactobacillus species as 'active ingredient' in relation to acne symptoms and skin microbiome modulation.
Interventions
OTHERTopical cream with live probiotic bacteria
Application of the probiotic cream once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as placebo cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).
OTHERPlacebo cream
Application of the placebo cream (same formulation as probiotic cream except live probiotic bacteria) once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as probiotic cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).
Sponsors
YUN NV
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
All AD patients will receive both treatments (verum and placebo). Verum cream will be applied on one side of the body (elbow or knee cavities), the placebo cream on the other side.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with atopic dermatitis and healthy volunteers
Exclusion criteria
AD patients: * no use of topical antibiotics and/or corticosteroids within 2 weeks before the start * no use of oral antibiotics within 1 month before the start * no immunodeficiency disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in skin microbiome composition | AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: skin swab at baseline and after 12 weeks (no product use).. | Extraction of microbial DNA out of skin swabs. Analysis of differences in bacterial communities colonizing the skin between healthy individuals and AD patients measured via Next Generation Sequencing techniques and qPCR assays. |
| Change from baseline in AD severity scoring based on Eczema Area and Severity Index | AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: NA | Evaluation of atopic dermatitis symptoms via a scoring system based on Eczema Area and Severity Index (EASI). The EASI will be adjusted to the limited area of elbow or knee cavities. |
| Change from baseline in itching via Visual Analogue Scale | AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). | The effect of the treatment of itching of the skin caused by atopic dermatitis lesions will be evaluated using Visual Analogue Scale (VAS). |
Countries
Belgium
Contacts
Primary ContactSarah Lebeer, Prof
Backup ContactLize Delanghe, Msc
Outcome results
None listed