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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.
Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta [TGF - β]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiatop | Experimental | Probiotic comprising the mixture of strains: Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus paracasei and Bifidobacterium lactis, at a dose of 1 gram sachet, once a day for 6 months |
|
| Placebo | Placebo Comparator | Placebo of Maltodextrin in sachet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiatop | Drug | Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD | Change from baseline in SCORAD every 3 months for 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Skin prick test (immediate awareness) | 1 year | |
| Inflammation composite | ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor | 1 year |
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Inclusion Criteria:
No inclusion / Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula A Andrade, MD | HCFMRP-USP | Principal Investigator |
| Persio Roxo-Junior, MD, PhD | HCFMRP-USP | Study Director |
| Vanessa Carregaro, PhD | USP-RP | Study Chair |
| Jorgete Maria e Silva, MD, Msc | HCFMRP-USP | Study Chair |
| Luciana Roberti | FMRP-USP | Study Chair |
| Laís Sacramento, Msc | USP-RP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas FMRP-USP | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D007249 | Inflammation |
| 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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| Placebo | Drug | 1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning. |
|
|
| Immune tolerance composite | IL-10, TGF - β and IL -17 | 1 year |
| Total serum IgE | 1 year |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |