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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotics | Active Comparator |
| |
| maltodextrin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotics | Dietary Supplement | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:Adults aged 18-55 years between
Exclusion Criteria:Allergic contact dermatitis (ACD), active
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| Name | Affiliation | Role |
|---|---|---|
| lorenzo drago, prof | Microbiology, Department of Clinical Sciences L. Sacco, University of Milan; 5Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luigi Sacco Hospital | Milan | 20157 | Italy |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| maltodextrin | Other | sachets |
|
| 20 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D019602 |
| Food and Beverages |