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

Abstract

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% PP P=0.017, CI95% 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 VSL#3 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 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.

Specific probiotic dietary supplementation leads to different effects during remission and relapse in murine chronic colitis

“…Evidence has shown that the administration of probiotics to patients suffering from IBD can restore the microbiota composition and induce beneficial effects (Ringel et al, 2012;Vanderpool et al, 2008). In patients suffering from UC, the clinical efficacy of probiotics was demonstrated by administration of VSL#3 that resulted in a remission in adult patients with active UC (Sood et al, 2009;Tursi et al, 2010) and in children (Miele et al, 2009). In addition, treatment with L. rhamnosus GG was effective in maintaining remission in patients suffering from UC (Zocco et al, 2006).…”

Potential Application of Probiotics in the Prevention and Treatment of Inflammatory Bowel Diseases

“…It has recently been suggested that there is a lack of welldesigned, large, randomized, placebo-controlled trials that can certify that probiotics are effective in the prevention and treatment of IBD [125]. Additional studies such as the double-blind, randomized, placebo-controlled clinical trial of the treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment [126] are required to confirm animal data and are necessary to convince the medical and general community of the benefits and potential application of probiotics in the prevention and treatment of IBD.…”

Ulcerative Colitis in Children and Adolescents

“…Recent studies have focused on VSL#3, a high-potency probiotic mixture, in adult and paediatric UC. A recent Italian study in adults with UC demonstrated that VSL#3 supplementation was safe and effective, with reduction in disease activity scores and symptoms (Tursi et al 2010). An earlier paediatric study evaluated the same probiotic therapy in 29 children with newly-diagnosed active UC using a randomised placebocontrolled design (Miele et al, 2009).…”