The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis. VSL#3 Probiotic-Mixture Induces Remission in Patients with 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. Effect of a Probiotic Preparation (VSL#3) on Induction and Maintenance of Remission in Children With Ulcerative Colitis 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 Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial.
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 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 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 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 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 BACKGROUND & AIMS Pouchitis is the major long-term complication after ileal pouch-anal anastomosis for ulcerative colitis . Most patients have relapsing disease , and no maintenance treatment study has been performed . We evaluated the efficacy of a probiotic preparation ( VSL#3 ) containing 5 x 10(11 ) per gram of viable lyophilized bacteria of 4 strains of lactobacilli , 3 strains of bifidobacteria , and 1 strain of Streptococcus salivarius subsp . thermophilus compared with placebo in maintenance of remission of chronic pouchitis . METHODS Forty patients in clinical and endoscopic remission were r and omized to receive either VSL#3 , 6 g/day , or an identical placebo for 9 months . Patients were assessed clinical ly every month and endoscopically and histologically every 2 months or in the case of a relapse . Fecal sample s were collected for stool culture before and after antibiotic treatment and each month during maintenance treatment . RESULTS Three patients ( 15 % ) in the VSL#3 group had relapses within the 9-month follow-up period , compared with 20 ( 100 % ) in the placebo group ( P < 0.001 ) . Fecal concentration of lactobacilli , bifidobacteria , and S. thermophilus increased significantly from baseline levels only in the VSL#3-treated group ( P < 0.01 ) . CONCLUSIONS These results suggest that oral administration of this new probiotic preparation is effective in preventing flare-ups of chronic pouchitis
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 .