A RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND THE EFFECT OF A PROBIOTIC MIXTURE ON PASI INDEX IN PATIENTS WITH MODERATE PSORIASIS

Introduction: In this clinical trial we hypothesized that the use of probiotic may play a role in the outcome of psoriasis. Objectives: To determine the response to treatment, defined as an improving of the PASI index higher of 75%. Secondary objectives: changes in the PGA index, inflammatory biomarkers in blood and side effects Methods: From September 2015 to October 2016 ninety patients with psoriasis were randomized to receive probiotic vs placebo during 12 weeks. Blood count, biochemical and biomarkers (TNF‐α, IF‐γ, IL‐1b, IL‐6, IL‐12, IL‐23) were measured. Gut microbiome analysis of stool samples were carried out. Results: In the intermediate evaluation at week six, 15 of 45 (33.3%)p. in the probiotic group and 5 of 43 (11.4%) in the placebo group (p=0.016) reach a PASI75 response. At the end of the 12 weeks intervention period this differences increase to 30 of 45 (66.7%) Vs 19 of 43 (44.9%); p=0.013. Difference was also observed in the blood levels of TNF when comparing the group of patients with PASI75 response (decrease of 2,33±16,7) and the group of patients without response (increase of 1,31±13,35). At the end of the 12 weeks framework (after stop treatment), patients were evaluated in to assess the occurrence of relapse in a period of 24 weeks outcome. Data shows a lower incidence of flares in the probiotic group: 9 of 45p. (20.0%) Vs 18 of 43 (41.9%); p=0.01 Conclusions: The results of our study indicate a strong positive effect in the group treated with the probiotic. It is also important that the number of new outbreaks after stopping treatment is lower in the probiotic group.