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.
Author(s): Tursi A, Brandimarte G, Papa A, Giglio A, Elisei W, Giorgetti GM, Forti G, Morini S, Hassan C, Pistoia MA, Modeo ME, Rodino' S, D'Amico T, Sebkova L, Sacca' N, Di Giulio E, Luzza F, Imeneo M, Larussa T, Di Rosa S, Annese V, Danese S, Gasbarrini A
Affiliation(s): "Lorenzo Bonomo" Hospital, Andria, Italy. firstname.lastname@example.org
Publication date & source: 2010-10, Am J Gastroenterol., 105(10):2218-27. Epub 2010 Jun 1.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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)(%) 0.51-0.74; intention to treat (ITT) P=0.031, CI(%) 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(%) 0.51-0.74; ITT P=0.046, CI(%) 0.47-0.69) and in rectal bleeding (PP P=0.014, CI(%) 0.46-0.70; ITT P=0.036, CI(%) 0.41-0.65), whereas stool frequency (PP P=0.202, CI(%) 0.39-0.63; ITT P=0.229, CI(%) 0.35-0.57), physician's rate of disease activity (PP P=0.088, CI(%) 0.34-0.58; ITT P=0.168, CI(%) 0.31-0.53), and endoscopic scores (PP P=0.086, CI(%) 0.74-0.92; ITT P=0.366, CI(%) 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(%) 0.36-0.60; ITT P=0.132, CI(%) 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.