Adult Atopic Dermatitis
Conditions
Brief summary
Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and prevention but their precise role is not yet clear. The aim of this randomized double blinded active treatment vs placebo study was to evaluate clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius LS01 and Bifidobacterium breve BR03) for the treatment of adult AD patients. The rationale for the use of probiotics in the treatment of atopic dermatitis would be due to some experimental hypotheses: 1. The use of these microbial agents at an early age seems to play an important role in inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE mediated 2. the normal intestinal flora (including probiotics) would play an important role in inducing immunological tolerance 3. the hygiene hypothesis that the reduced bacterial environment would favour a type 2 response T and the development of allergic diseases
Interventions
DIETARY_SUPPLEMENTprobiotics
a mixture of Lactobacillus LS01 DSM 2275 and Bifidobacterium BR03 DSM 16604 at a dose of 1 x 109 colony forming units (CFU)/g each in maltodextrin
OTHERmaltodextrin
sachets
Sponsors
ASST Fatebenefratelli Sacco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Adults aged 18-55 years between * Diagnosis of DA moderate and / or severe, as assessed by the use of a standardized index of severity of AD (SCORAD = Scoring Atopic Dermatitis index) (42), prepared by the European Task Force for atopic dermatitis
Exclusion criteria
Allergic contact dermatitis (ACD), active * In the absence of known food allergy elimination diet * Chronic diseases (autoimmune diseases, COPD, heart disease, IRC, CNS disease, chronic gastrointestinal diseases, diabetes, congenital or acquired immunosuppression) * Pregnancy and / or lactation * Treatment with probiotics in the 6 months preceding enrollment * Treatment with steroids and antihistamines systemically in the three months prior to enrollment * Topical treatments with immunomodulators (tacrolimus or pimecrolimus) in the three months prior to enrollment * Acute or chronic infectious diseases * Pre-existing hypersensitivity to components contained in the probiotic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical effects of probiotics on adult atopic dermatitis | 20 weeks | To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis | 20 weeks | to evaluate these parameters: percentage of circulating Treg cells, percentage of Th17 cells, Th1 and Th2, percentage of Treg cells TLR2+, TLR4 + and TLR9 +, Quantization plasma LPS. Determination by gene amplification and culture of Lactobacillus salivarius and Bifidobacterium in the faeces of the two groups studied |
Countries
Italy
Outcome results
None listed