Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children
Overview
- Phase
- Phase 4
- Intervention
- Probiatop
- Conditions
- Atopic Dermatitis
- Sponsor
- Casa Espirita Terra de Ismael
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- SCORAD
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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]).
Investigators
Fabio Carmona
University of Sao Paulo
Casa Espirita Terra de Ismael
Eligibility Criteria
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)
Arms & Interventions
Probiatop
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
Intervention: Probiatop
Placebo
Placebo of Maltodextrin in sachet
Intervention: Placebo
Outcomes
Primary Outcomes
SCORAD
Time Frame: 1 year
Change from baseline in SCORAD every 3 months for 1 year
Secondary Outcomes
- Inflammation composite(1 year)
- Immune tolerance composite(1 year)
- Total serum IgE(1 year)
- Skin prick test (immediate awareness)(1 year)