Treatment of Relapsing Mild-to-Moderate Ulcerative Colitis With the Probiotic VSL#3 as Adjunctive to a Standard Pharmaceutical Treatment: A Double-Blind, Randomized, Placebo-Controlled Study

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OBJECTIVES:VSL#3 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 VSL#3 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 VSL#3 at a dose of 3,600 billion CFU/day (71 patients) or with placebo (73 patients).RESULTS:In all, 65 patients in the VSL#3 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 VSL#3 group than in the placebo group (63.1 vs. 40.8; per protocol (PP)P=0.010, confidence interval (CI)95% 0.51–0.74; intention to treat (ITT)P=0.031, CI95% 0.47–0.69). Significant results with VSL#3 were recorded in an improvement of three points or more in the UCDAI score (60.5% vs. 41.4%; PPP=0.017, CI95% 0.51–0.74; ITTP=0.046, CI95% 0.47–0.69) and in rectal bleeding (PPP=0.014, CI95% 0.46–0.70; ITTP=0.036, CI95% 0.41–0.65), whereas stool frequency (PPP=0.202, CI95% 0.39–0.63; ITTP=0.229, CI95% 0.35–0.57), physician's rate of disease activity (PPP=0.088, CI95% 0.34–0.58; ITTP=0.168, CI95% 0.31–0.53), and endoscopic scores (PPP=0.086, CI95% 0.74–0.92; ITTP=0.366, CI95% 0.66–0.86) did not show statistical differences. Remission was higher in the VSL#3 group than in the placebo group (47.7% vs. 32.4%; PPP=0.069, CI95% 0.36–0.60; ITTP=0.132, CI95% 0.33–0.56). Eight patients on VSL#3 (11.2%) and nine patients on placebo (12.3%) reported mild side effects.CONCLUSIONS:VSL#3 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, VSL#3 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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