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

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, CI(95%) 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% PP P=0.017, CI(95%) 0.51–0.74; ITT P=0.046, CI(95%) 0.47–0.69) and in rectal bleeding (PP P=0.014, CI(95%) 0.46–0.70; ITT P=0.036, CI(95%) 0.41–0.65), whereas stool frequency (PP P=0.202, CI(95%) 0.39–0.63; ITT P=0.229, CI(95%) 0.35–0.57), physician's rate of disease activity (PP P=0.088, CI(95%) 0.34–0.58; ITT P=0.168, CI(95%) 0.31–0.53), and endoscopic scores (PP P=0.086, CI(95%) 0.74–0.92; ITT P=0.366, CI(95%) 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% PP P=0.069, CI(95%) 0.36–0.60; ITT P=0.132, CI(95%) 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.