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

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, confi dence interval (CI) 95 % 0.51 – 0.74; intention to treat (ITT) P = 0.031, CI 95 % 0.47 – 0.69). Signifi cant 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 signifi cance.