Probiotics in Adults: do They Improve Atopic Dermatitis?

Study Overview
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Brief Summary
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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: 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 the normal intestinal flora (including probiotics) would play an important role in inducing immunological tolerance the hygiene hypothesis that the reduced bacterial environment would favour a type 2 response T and the development of allergic diseases

Official Title
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Evaluation of the Effects of a Combination of Probiotics in the Treatment of Adult Atopic Dermatitis: Randomized Phase III, Double-blind Placebo-controlled

Conditions
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Adult Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: probiotics
* Other: maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: probiotics<br> | Dietary Supplement: probiotics<br>* 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<br>|
| Placebo Comparator: maltodextrin<br> | Other: maltodextrin<br>* sachets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical effects of probiotics on adult atopic dermatitis | To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis | 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 | 20 weeks |