title: 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 The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials VSL#3 Probiotic-Mixture Induces Remission in Patients with Active Ulcerative Colitis Effect of a Probiotic Preparation (VSL#3) on Induction and Maintenance of Remission in Children With Ulcerative Colitis The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis. Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis.
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 r and omly 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 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND AND AIMS : Intestinal bacteria have been implicated in the initiation and perpetuation of IBD ; in contrast , “ probiotic bacteria ” have properties possibly effective in treating and preventing relapse of IBD . We evaluated the safety and efficacy of VSL#3 and the components , and the composition of the biopsy-associated microbiota in patients with active mild to moderate ulcerative colitis ( UC ) . METHODS : Thirty-four ambulatory patients with active UC received open label VSL#3 , 3,600 billion bacteria daily in two divided doses for 6 wk . The presence of biopsy-associated bacteria was detected using a nucleic acid-based method and the presence of VSL#3 species confirmed by DNA sequencing of 16S rRNA . RESULTS : Thirty-two patients completed 6 wk of VSL#3 treatment and 2 patients did not have the final endoscopic assessment . Intent to treat analysis demonstrated remission ( UCDAI ≤ 2 ) in 53 % ( n = 18 ) ; response ( decrease in UCDAI ≥ 3 , but final score ≥3 ) in 24 % ( n = 8) ; no response in 9 % ( n = 3 ) ; worsening in 9 % ( n = 3 ) ; and failure to complete the final sigmoidoscopy assessment in 5 % ( n = 2 ) . There were no biochemical or clinical adverse events related to VSL#3 . Two of the components of VSL#3 were detected by PCR/DGGE in biopsies collected from 3 patients in remission . CONCLUSION : Treatment of patients with mild to moderate UC , not responding to conventional therapy , with VSL#3 result ed in a combined induction of remission/response rate of 77 % with no adverse events . At least some of the bacterial species incorporated in the probiotic product reached the target site in amounts that could be detected 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 BACKGROUND & AIMS Probiotics can maintain ulcerative colitis ( UC ) in remission effectively , but little is known of their ability to induce remission . We conducted a multicenter , r and omized , double-blind , placebo-controlled trial of a high-potency probiotic , VSL#3 , for the treatment of mild-to-moderately active UC . METHODS Adult patients with mild-to-moderate UC were assigned r and omly to groups that were given 3.6 x 10(12 ) CFU VSL#3 ( n = 77 ) or placebo ( n = 70 ) , twice daily for 12 weeks . The primary end point was a 50 % decrease in the Ulcerative Colitis Disease Activity Index ( UCDAI ) at 6 weeks . The secondary end points included remission by 12 weeks and reduction in total individual UCDAI parameters from baseline at 12 weeks . Intention-to-treat analysis was performed . RESULTS At week 6 , the percentage of patients with an improvement in UCDAI score that was greater than 50 % was significantly higher in the group given VSL#3 ( 25 ; 32.5 % ) than the group given placebo ( 7 ; 10 % ) ( P = .001 ) . At week 12 , there were 33 patients given VSL#3 ( 42.9 % ) who achieved remission , compared with 11 patients given placebo ( 15.7 % ) ( P < .001 ) . Furthermore , significantly more patients given VSL#3 ( 40 ; 51.9 % ) achieved a decrease in their UCDAI that was greater than 3 points , compared with those given placebo ( 13 ; 18.6 % ) ( P < .001 ) . The VSL#3 group had significantly greater decreases in UCDAI scores and individual symptoms at weeks 6 and 12 , compared with the placebo group . CONCLUSIONS VSL#3 is safe and effective in achieving clinical responses and remissions in patients with mild-to-moderately active UC BACKGROUND Balsalazide is well tolerated and effective in treating acute ulcerative colitis .  VSL#3 is a probiotic cocktail proven to be effective in preventing flare-ups of chronic pouchitis . We compared the efficacy and safety of low-dose balsalazide ( 2.25 g/day ) plus 3 g/day VLS#3 ( group A ) with medium-dose balsalazide alone ( group B ) and with mesalazine ( group C ) in the treatment of mild-to-moderate active ulcerative colitis . MATERIAL / METHODS Ninety patients ( 30 per group ) were r and omly enrolled , with a treatment duration of 8 weeks .  Efficacy was assessed by symptoms assessment , endoscopic appearance , and histological evaluation . RESULTS Balsalazide/VSL#3 was significantly superior to balsalazide alone and to mesalazine in obtaining remission : 24 patients of group A were in remission [ per- protocol : 85.71 % ( C.I.95 % : 62 - 96 ) , on intention-to-treat : 80 % ( C.I.95 % : 59 - 91 ) ] , while 21 group B [ per- protocol : 80.77 % ( C.I. 95 % : 51 - 82 ) , on intention-to-treat : 77 % ( C.I.95 % : 43 - 81 ) ] and 16 group C patients [ per- protocol : 72.73 % ( C.I. 95 % : 30 - 75 ) , on intention-to-treat : 53.33 % ( C.I.95 % : 42 - 62 ) ] were in remission ( p<0.02 ) . Balsalazide with or without VSL#3 was better tolerated than mesalazine : two group C patients were withdrawn from the study because of severe side-effects ; 1 group A ( 3.33 % ) , 3 group B ( 10 % ) and 4 group C ( 13.33 % ) patients experienced slight side-effects . The balsalazide/VSL#3 combination was faster in obtaining remission than balsalazide alone or mesalazine ( 4 , 7.5 , and 13 days in groups A , B and C , respectively ) and also better in improving all parameters evaluated . CONCLUSIONS Balsalazide/VSL#3 may be a very good choice in the treatment of active mild-to-moderate active ulcerative colitis instead of balsalazide alone or mesalazine
target: 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: 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 .