Atopic Dermatitis
Conditions
Keywords
Probiotics, Inflammation, Awareness, Immune tolerance
Brief summary
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 \[TGF - β\]).
Interventions
DRUGProbiatop
Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.
DRUGPlacebo
1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.
Sponsors
University of Sao Paulo
Casa Espirita Terra de Ismael
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 19 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD | 1 year | Change from baseline in SCORAD every 3 months for 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin prick test (immediate awareness) | 1 year | — |
| Inflammation composite | 1 year | ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor |
| Immune tolerance composite | 1 year | IL-10, TGF - β and IL -17 |
| Total serum IgE | 1 year | — |
Countries
Brazil
Outcome results
None listed