Effect of Oral Administration of a Mixture of Probiotic Strains on SCORAD Index and Use of Topical Steroids in Young Patients With Moderate Atopic Dermatitis: A Randomized Clinical Trial.

IMPORTANCE: Oral intake of new probiotic formulations may improve the course of atopic dermatitis (AD) in a young population. OBJECTIVE: To determine whether a mixture of oral probiotics is safe and effective in the treatment of AD symptoms and to evaluate its influence on the use of topical steroids in a young population. DESIGN, SETTING, AND PARTICIPANTS: A 12-week randomized, double-blind, placebo-controlled intervention trial, from March to June 2016, at the outpatient hospital Centro Dermatológico Estético de Alicante, Alicante, Spain. Observers were blinded to patient groupings. Participants were children aged 4 to 17 years with moderate atopic dermatitis. The groups were stratified and block randomized according to sex, age, and age of onset. Patients were ineligible if they had used systemic immunosuppressive drugs in the previous 3 months or antibiotics in the previous 2 weeks or had a concomitant diagnosis of intestinal bowel disease or signs of bacterial infection. INTERVENTIONS: Twelve weeks with a daily capsule containing freeze-dried powder with 109 total colony-forming units of the probiotic strains Bifidobacterium lactis CECT 8145, B longum CECT 7347, and Lactobacillus casei CECT 9104 and maltodextrin as a carrier, or placebo (maltodextrin-only capsules). MAIN OUTCOMES AND MEASURES: SCORAD index score and days of topical steroid use were analyzed. RESULTS: Fifty children (26 [50%] female; mean [SD] age, 9.2 [3.7] years) participated. After 12 weeks of follow-up, the mean reduction in the SCORAD index in the probiotic group was 19.2 points greater than in the control group (mean difference, -19.2; 95% CI, -15.0 to -23.4). In relative terms, we observed a change of -83% (95% CI, -95% to -70%) in the probiotic group and -24% (95% CI, -36% to -11%) in the placebo group (P < .001). We found a significant reduction in the use of topical steroids to treat flares in the probiotic arm (161 of 2084 patient-days [7.7%]) compared with the control arm (220 of 2032 patient-days [10.8%]; odds ratio, 0.63; 95% CI, 0.51 to 0.78). CONCLUSIONS AND RELEVANCE: The mixture of probiotics was effective in reducing SCORAD index and reducing the use of topical steroids in patients with moderate AD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02585986.