CONCLUSIONS VSL#3 , when added to conventional therapy at a daily dose of 3.6 × 10 CFU/d , is safe and more effective than conventional therapy alone in achieving higher response and remission rates in mild to moderately active ulcerative colitis
BACKGROUND VSL#3 is a probiotic mix preparation reported to be effective in the treatment of mild to moderately active ulcerative colitis .
We aim ed to perform a systematic review of the literature and a meta- analysis of studies on its efficacy .
Effect of a Probiotic Preparation (VSL#3) on Induction and Maintenance of Remission in Children With Ulcerative Colitis
OBJECTIVES : Several probiotic compounds have shown promise in the therapy of ulcerative colitis ( UC ) . However , a strong sustained benefit remains to be seen . Uncontrolled pilot studies suggest that a probiotic preparation ( VSL#3 ) maintains remission in mild to moderate UC and reduces active inflammation in adult patients . Aims of our prospect i ve , 1-year , placebo-controlled , double-blind study were to assess the efficacy of VSL#3 on induction and maintenance of remission and to evaluate the safety and tolerability of the probiotic preparation therapy in children with active UC . METHODS : A total of 29 consecutive patients ( mean age : 9.8 years ; range : 1.7–16.1 years ; female/male : 13/16 ) with newly diagnosed UC were r and omized to receive either VSL#3 ( weight-based dose , range : 450–1,800 billion bacteria/day ; n=14 ) or an identical placebo ( n=15 ) in conjunction with concomitant steroid induction and mesalamine maintenance treatment . Children were prospect ively evaluated at four time points : within 1 month , 2 months , 6 months , and 1 year after diagnosis or at the time of relapse . Lichtiger colitis activity index and a physician 's global assessment were used to measure disease activity . At baseline , within 6 months and 12 months or at the time of relapse , all patients were assessed endoscopically and histologically . RESULTS : All 29 patients responded to the inflammatory bowel disease ( IBD ) induction therapy . Remission was achieved in 13 patients ( 92.8 % ) treated with VSL#3 and IBD therapy and in 4 patients ( 36.4 % ) treated with placebo and IBD therapy ( P<0.001 ) . Overall , 3 of 14 ( 21.4 % ) patients treated with VSL#3 and IBD therapy and 11 of 15 ( 73.3 % ) patients treated with placebo and IBD therapy  relapsed within 1 year of follow-up ( P=0.014 ; RR=0.32 ; CI=0.025–0.773 ; NNT=2 ) . All 3 patients treated with VSL#3 and 6 of 11 ( 54.5 % ) patients treated with placebo  relapsed within 6 months of diagnosis . At 6 months , 12 months , or at time of relapse , endoscopic and histological scores were significantly lower in the VSL#3 group than in the placebo group ( P<0.05 ) . There were no biochemical or clinical adverse events related to VSL#3 . CONCLUSIONS : This is the first pediatric , r and omized , placebo-controlled trial that suggests the efficacy and safety of a highly concentrated mixture of probiotic bacterial strains ( VSL#3 ) in active UC and demonstrates its role in maintenance of remission
CONCLUSIONS VSL#3 , when added to conventional therapy at a daily dose of 3.6 × 10 CFU/d , is safe and more effective than conventional therapy alone in achieving higher response and remission rates in mild to moderately active ulcerative colitis
BACKGROUND VSL#3 is a probiotic mix preparation reported to be effective in the treatment of mild to moderately active ulcerative colitis .
We aim ed to perform a systematic review of the literature and a meta- analysis of studies on its efficacy .