Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Study Overview
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Brief Summary
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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]).

Official Title
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Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Probiatop
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Atopic Dermatitis Children over 6 months. Teens lower than 19 years No inclusion / Exclusion Criteria: Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research. Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days. Allergy or severe adverse reactions attributable to the administration of the probiotic. Non adherence to treatment (ie not present regular use, as prescribed) for at least one continuous month. Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held during the search. Patient's request (or responsible's request)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiatop<br>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 | Drug: Probiatop<br>* Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.<br>* Other names: Probiotics;|
| Placebo Comparator: Placebo<br>Placebo of Maltodextrin in sachet | Drug: Placebo<br>* 1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.<br>* Other names: Maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD | Change from baseline in SCORAD every 3 months for 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Immune tolerance composite | IL-10, TGF - β and IL -17 | 1 year | 
| Total serum IgE |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Probiotics, Awareness, Immune tolerance