NCT02519556

Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Casa Espirita Terra de Ismael · Academic / Other
• Sex: All
• Age: 6 Months – 19 Years
• Healthy volunteers: Not accepted

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 \[TGF - β\]).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Probiatop	Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.
DRUG	Placebo	1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-08-11
• Last updated: 2021-01-28

Locations

1 site across 1 country: Brazil