Table 3.

Trials assessing the effect of VSL#3 in patients with ulcerative colitis

Ref.	Design	n	VSL#3 intake
Venturi et al[66], 1999	Not mentioned	20 with UC who were intolerant or allergic to 5-ASA	12 mo with 3 g, 5 × 1011 cells/g, twice a day
Tursi et al[70], 2004	Multicenter, randomized trial	90 with newly diagnosed or recently relapsed mild-to-moderate UC	8 wk with 3 g a day, 1 g bags contained 3 × 1011 viable lyophilized bacteria
Bibiloni et al[71], 2005	Open-label trial	34 ambulatory patients with active UC; 32 patients completed	6 wk with 3.6 × 1012 bacteria a day in two divided doses
Soo et al[72], 2008	Not mentioned	15 patients with UC	5 wk with 1 sachet (containing 9 × 1011 lyophilized bacteria) twice a day
Sood et al[68], 2009	RCT	147 with active mild-to-moderate UC (including 77 with VSL#3 and 70 with placebo)	12 wk with 3.6 × 1012 CFU twice a day
Huynh et al[74], 2009	Open-label study	18 patients between ages of 3 and 17 with mild-to-moderate acute UC	One dose of VSL#3 sachet containing 4.5 × 1011 viable lyophilized bacteria; patients were treated twice daily for 8 wk with a dose of VSL#3 based on their age, range: one-half sachet to two and one-half sachets
Miele et al[73], 2009	RCT	29 consecutive patients (mean age: 9.8 yr; range: 1.7 to 16.1 yr) with newly diagnosed UC (VSL#3 group: n = 14; placebo group: n = 15)	Weight-based dose, range: 4.5 × 1011 to 1.8 × 1012 bacteria a day, the treatment time was not clear
Tursi et al[67], 2010	RCT	144 with relapsing UC (including 71 with VSL#3 and 73 with placebo); 65 patients with VSL#3 and 66 with placebo completed	8 wk with 3.6 × 1012 CFU a day

UC: Ulcerative colitis; CFU: Colony-forming unit; RCT: Randomized controlled trial; 5-ASA: 5-aminosalicylic acid.