Objectives: VSL3 is a high-potency probiotic mixture that has been used successfully in the treatment of pouchitis. The primary end point of the study was to assess the effects of supplementation with VSL3 in patients affected by relapsing ulcerative colitis (UC) who are already under treatment with 5-aminosalicylic acid (ASA) and/or immunosuppressants at stable doses. Methods: A total of 144 consecutive patients were randomly treated for 8 weeks with VSL3 at a dose of 3,600 billion CFU/day (71 patients) or with placebo (73 patients). Results: In all, 65 patients in the VSL3 group and 66 patients in the placebo group completed the study. The decrease in ulcerative colitis disease activity index (UCDAI) scores of 50% or more was higher in the VSL3 group than in the placebo group (63.1 vs. 40.8; per protocol (PP) P=0.010, confidence interval CI95% 0.51-0.74; intention to treat (ITT) P=0.031, CI95% 0.47-0.69). Significant results with VSL3 were recorded in an improvement of three points or more in the UCDAI score (60.5% vs. 41.4%; PP P=0.017, CI 95% 0.51-0.74; ITT P=0.046, CI95% 0.47-0.69) and in rectal bleeding (PP P=0.014, CI95% 0.46-0.70; ITT P=0.036, CI95% 0.41-0.65), whereas stool frequency (PP P=0.202, CI95% 0.39-0.63; ITT P=0.229, CI95% 0.35-0.57), physician's rate of disease activity (PP P=0.088, CI95% 0.34-0.58; ITT P=0.168, CI95% 0.31-0.53), and endoscopic scores (PP P=0.086, CI95% 0.74-0.92; ITT P=0.366, CI95% 0.66-0.86) did not show statistical differences. Remission was higher in the VSL3 group than in the placebo group (47.7% vs. 32.4%; PP P=0.069, CI95% 0.36-0.60; ITT P=0.132, CI95% 0.33-0.56). Eight patients on VSL3 (11.2%) and nine patients on placebo (12.3%) reported mild side effects. Conclusions: VSL3 supplementation is safe and able to reduce UCDAI scores in patients affected by relapsing mild-to-moderate UC who are under treatment with 5-ASA and/or immunosuppressants. Moreover, VSL3 improves rectal bleeding and seems to reinduce remission in relapsing UC patients after 8 weeks of treatment, although these parameters do not reach statistical significance.
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