SP367PROBIOTICKD: A MONOCENTRIC, RANDOMIZED, OPEN-LABEL, PLACEBO-CONTROLLED STUDY TO REVEAL AND CORRECT GUT DYSBIOSIS IN EARLY CKD STAGES

Abstract

INTRODUCTION AND AIMS: Gut dysbiosis has been described in advanced CKD stages but not in initial disease. Considering the relevant impact of gut dysbiosis on renal and cardiovascular risk, its diagnosis and treatment are important issues. METHODS: We present a monocentric, randomized, open‐label, placebo‐controlled study. Gut microbiota and its metabolism were studied in a cohort of stable KDIGO stage II‐IIIa CKD patients (n=28) at baseline and after a randomly assigned treatment with probiotics or placebo.Gut microbiota health status was assessed by fecal Lactobacillales and Bifidobacteria concentrations. Urinary indican and 3‐methylindole (3‐MI) were measured to study gut microbiota metabolism. The impact of the treatment on biochemistry lab parameters was also assessed. RESULTS: At baseline, in both placebo and probiotics groups, mean fecal Lactobacillales and Bifidobacteria concentrations were abnormally low, while urinary indican and 3‐MI levels were high, as expression of a mixed (fermentative and putrefactive) dysbiosis. After treatment, mean fecal Lactobacillales and Bifidobacteria concentrations were increased only in the probiotics group (p<0.001). Conversely, mean urinary indican and 3‐MI levels were both reduced only in the group treated with probiotics (p<0.001). Compared to placebo group, significant improvements of Creactive protein (p<0.001), iron (p<0.001), transferrin saturation (p<0.001), and beta‐2‐microglobulin (p<0.001) were observed only in the probiotics group. CONCLUSIONS: ProbiotiCKD is the first intervention study demonstrating that an intestinal mixed dysbiosis is present even in the earlier stages of CKD and that it can be effectively corrected by the novel mode of administration of high quality probiotics tested in the study.