Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Casa Espirita Terra de Ismael

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Probiatop

Study type: Interventional

Funder types: Other

Identifiers

NCT02519556

ProbioticsAD2015

Details and patient eligibility

About

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]).

Enrollment: 60 patients

Sex: All

Ages: 6 months to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Probiatop

Experimental group

Description:

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

Treatment:

Drug: Probiatop

Placebo

Placebo Comparator group

Description:

Placebo of Maltodextrin in sachet

Treatment:

Drug: Placebo