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Background Intestinal microbiota is altered in patients with Atopic Dermatitis (AD) when compared to that of the healthy population. Some interventions with specific probiotic preparations already demonstrate a change in the composition of this microbiota accompanied by an improvement of the disease. Objectives This research work, is designed to evaluate the clinical efficacy of the probiotic and to measure the effect of the intervention on the total dose of corticosteroids administered to subjects. Methods A double-blind, randomized, placebo-controlled clinical trial including AD participants, aged 4 to 17 years, to evaluate the clinical effect of a probiotic mixture of Bifidobacterium lactis, Bifidobacterium longum and Lactobacillus casei in a total daily consumption of 1x109. The analyzed clinical variables are the SCORAD (Scoring of Atopic Dermatitis) and IGA (Investigator Global Assessment) indices, the effect on the consumption of topical corticosteroids and the assessment of safety. Results SCORAD index score at 12 weeks shows a statistically significant difference of -5.43 (-10.65 to -0.21) between the probiotic (SCORAD 13.52) and placebo groups (SCORAD 18.96); p=0.04. Comparison between groups shows statistically significant difference in the number of patients with IGA score improvement over the 12-week intervention: 29 (90.5%) patients in the probiotic group and 17 (56.7%) patients in the placebo group (p<0.002). A comparison between groups of the proportions of days using corticosteroids and the total grams of corticosteroids between baseline and end of study shows no significant difference, but between weeks 6-12 there is a statistically significant reduction in the probiotic group when compared with the placebo group in both variables. The numbers of adverse events are similar in both groups of treatment. Conclusions The probiotic used in this clinical trial demonstrates efficacy on the change of the activity index of AD compared to placebo. The total number of days and total amount of topical corticosteroids required by the subjects in the probiotic group showed a significant reduction compared to placebo between 6-12 weeks.

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