VSL#3 Probiotic-Mixture Induces Remission in Patients with Active Ulcerative Colitis The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active 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 Effect of a Probiotic Preparation (VSL#3) on Induction and Maintenance of Remission in Children With Ulcerative Colitis A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea‐predominant irritable bowel syndrome Prophylaxis of pouchitis onset with probiotic therapy: A double‐blind, placebo‐controlled trial Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. 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. Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis Double‐blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease. Balsalazide and/or high-potency probiotic mixture (VSL#3) in maintaining remission after attack of acute, uncomplicated diverticulitis of the colon Clinical trial: probiotic treatment of acute distal ulcerative colitis with rectally administered Escherichia coli Nissle 1917 (EcN) Prophylaxis with whole gut irrigation and antimicrobials in colorectal surgery. A prospective, randomized double-blind clinical trial. The prophylactic use of probiotics in the prevention of radiation therapy-induced diarrhea. Impact on the composition of the faecal flora by a new probiotic preparation: preliminary data on maintenance treatment of patients with ulcerative colitis Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study.
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 & 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 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 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 Aim : To investigate the effects of a probiotic formulation , VSL#3 , on gastrointestinal transit and symptoms of patients with Rome II irritable bowel syndrome with predominant diarrhoea BACKGROUND & AIMS We have recently documented the efficacy of a highly concentrated probiotic preparation ( VSL#3 ) in the prevention of flare-up in patients with chronic pouchitis . The aim of this study was to compare probiotic therapy with VSL#3 versus placebo in the ability to prevent the onset of acute pouchitis during the first year after ileal pouch-anal anastomosis . METHODS Forty consecutive patients who underwent ileal pouch-anal anastomosis for ulcerative colitis were r and omized to receive either VSL#3 ( 1 packet containing 900 billion bacteria/day ) ( n = 20 ) or an identical placebo ( n = 20 ) immediately after ileostomy closure for 1 year . The patients were assessed clinical ly , endoscopically , and histologically after 1 , 3 , 6 , 9 , and 12 months . Health-related quality of life was assessed using the Inflammatory Bowel Disease Question naire . RESULTS Two of the 20 patients ( 10 % ) treated with VSL#3 had an episode of acute pouchitis compared with 8 of the 20 patients ( 40 % ) treated with placebo ( log-rank test , z = 2.273 ; P < 0.05 ) . Treatment with VSL#3 determined a significant improvement in Inflammatory Bowel Disease Question naire score , whereas this was not the case with placebo . CONCLUSIONS Treatment with VSL#3 is effective in the prevention of the onset of acute pouchitis and improves quality of life of patients with ileal pouch-anal anastomosis 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 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 Background : Ten to 15 % of patients with pouchitis experience refractory or recurrent disease . The aim of this study was to evaluate the effectiveness of a single daily high dose probiotic preparation ( VSL#3 ) in maintaining antibiotic induced remission , and quality of life ( QOL ) , for one year in such patients . Methods : Patients with pouchitis at least twice in the previous year or requiring continuous antibiotics , associated with a pouchitis disease activity index ( PDAI ) ⩾7 ( 0 = perfect ; 18 = worst ) , in whom remission was induced by four weeks of combined metronidazole and ciprofloxacin  , were r and omised to receive VSL#3 6 g or placebo once daily for one year or until relapse . Symptomatic , endoscopic , and histological evaluations were made before , and two and 12 months after r and omisation or at the time of relapse . Remission was defined as a clinical PDAI ⩽2 and endoscopic PDAI ⩽1 . Relapse was defined as an increased clinical PDAI score ⩾2 and increased endoscopic PDAI score ⩾3 . QOL was assessed using the inflammatory bowel disease question naire ( IBDQ ) . Results : Thirty six patients were r and omised : 20 to VSL#3 and 16 to  placebo . Remission was maintained at one year in 17 patients ( 85 % ) on VSL#3 and in one patient ( 6 % ) on placebo ( p<0.0001 ) . The IBDQ score remained high in the VSL#3 group ( p = 0.3 ) but deteriorated in the placebo group ( p = 0.0005 ) . Conclusion : The once daily high dose probiotic VSL#3 is effective in maintaining antibiotic introduced remission for at least a year in patients with recurrent or refractory pouchitis . This is associated with a high level of quality of life Aminosalicylates are used as st and ard treatment for maintaining remission in ulcerative colitis . As yet , there is no other existing alternative with proven efficacy . In light of the hypothesis that the intestinal environment may contribute to the pathophysiology of ulcerative colitis , a trial was conducted to test the effects of probiotic treatment with an oral preparation of non‐pathogenic E. coli BACKGROUND & AIMS Probiotic formulations of single species of bacteria have not been effective in preventing the recurrence of Crohn 's disease after surgery . We investigated the ability of VSL#3 , a mixture of 8 different bacterial probiotic species , to prevent Crohn 's disease recurrence after surgery in a multicenter , r and omized , double-blind , placebo-controlled trial . METHODS Within 30 days of ileocolonic resection and re-anastomosis , patients with Crohn 's disease were r and omly assigned to groups given 1 sachet of VSL#3 ( 900 billion viable bacteria , comprising 4 strains of Lactobacillus , 3 strains of Bifidobacterium , and 1 strain of Streptococcus salivarius subspecies thermophilus ) ( n = 59 ) or matching placebo ( n = 60 ) . Colonoscopy was performed at days 90 and 365 to evaluate the neoterminal ileum for disease recurrence and obtain mucosal biopsies for cytokine analysis . Patients from both groups with either no or mild endoscopic recurrence at day 90 received VSL#3 until day 365 . The primary outcome was the proportion of patients with severe endoscopic recurrence at day 90 . RESULTS At day 90 , the proportion of patients with severe endoscopic lesions did not differ significantly between VSL#3 ( 9.3 % ) and placebo ( 15.7 % , P = .19 ) . The proportions of patients with non-severe lesions at day 90 who had severe endoscopic recurrence at day 365 were 10.0 % in the early VSL#3 group ( given VSL#3 for the entire 365 days ) and 26.7 % in the late VSL#3 group ( given VSL#3 from days 90 through 365 ) ( P = .09 ) . Aggregate rates of severe recurrence ( on days 90 and 365 ) were not statistically different , 20.5 % of subjects in the early VSL#3 group and 42.1 % in the late VSL#3 group . Patients receiving VSL#3 had reduced mucosal inflammatory cytokine levels compared with placebo at day 90 ( P < .05 ) . Crohn 's disease activity index and inflammatory bowel disease quality of life scores were similar in the 2 groups . CONCLUSIONS There were no statistical differences in endoscopic recurrence rates at day 90 between patients who received VSL#3 and patients who received placebo . Lower mucosal levels of inflammatory cytokines and a lower rate of recurrence among patients who received early VSL#3 ( for the entire 365 days ) indicate that this probiotic should be further investigated for prevention of Crohn 's disease recurrence . Clinical trials.gov number : NCT00175292 Background and aims The role of probiotics in the treatment of diverticulitis is still not known . The aim of our study was to investigate whether balsalazide and /or VSL#3 is effective in preventing diverticulitis recurrence . Material s and methods In this pilot study , 30 consecutive patients ( 19 males , 11 females , mean age 60.1 years , range 47–75 years ) affected by uncomplicated diverticulitis of the colon were monitored . After obtaining remission , the patients were r and omly assigned to one of the following groups as follows : group A , balsalazide 2.25 g daily for 10 days every month plus VSL#3 450 billions/day for 15 days every month and group B , VSL#3 alone 450 billions/day for 15 days every month . Primary end-point was considered the maintaining of remission throughout a 12-month follow-up . Secondary end-points considered were ( 1 ) the assessment of the overall scores at the end of the follow-up and ( 2 ) the effects of the two different treatments with regards to every symptom assessed . Results / findings One group A patient was withdrawn from the study at the 6th month and one group B patient was lost at the 6th month of follow-up . One group A patient ( 6.66 % ) showed relapse of symptoms at the 10th month of follow-up . At the end of follow-up , 11 patients were completely symptom-free ( 73.33 % ) , whilst 2 patients complained of only mild , recurrent symptoms ( 13 % ) . Two group B patients ( 13.33 % ) showed relapse of the disease at the 5th and 8th month of follow-up , respectively . At the end of follow-up , 8 patients were completely symptom-free ( 60 % ) , 2 patients complained of mild , recurrent symptoms ( 13.33 % ) , 1 patient ( 6.66 % ) complained of mild but continuous symptoms . No side effects were recorded throughout the follow-up in both groups . Interpretation/ conclusions Combination probiotic/anti-inflammatory drug was found better than probiotic treatment in preventing relapse of uncomplicated diverticulitis of the colon , even if without statistical significance Background Probiotics are effective in inflammatory bowel diseases . Clinical effectiveness and dose dependency of E. coli Nissle ( EcN ) enemas were investigated in ulcerative colitis ( UC ) . Methods In a double-blind study , 90 patients with moderate distal activity in UC were r and omly assigned to treatment with either 40 , 20 , or 10 ml enemas ( N = 24 , 23 , 23 ) containing 10E8 EcN/ml or placebo ( N = 20 ) . The study medication was taken once daily for at least 2 weeks . After 2 , 4 and /or 8 weeks the clinical DAI was assessed together with tolerance to treatment . Patients who reached clinical DAI ≤ 2 within that time were regarded as responders . Results According to ITT analysis the number of responders was not significantly higher in the EcN group than in the placebo group ( p = 0.4430 , 2-sided ) . However , the Jonckheere-Terpstra rank correlation for dose-dependent efficacy indicated a significant correlation of per- protocol responder rates ( p = 0.0446 , 2-sided ) . Time to remission was shortest with EcN 40 ml , followed by EcN 20 ml . The number of adverse events did not differ notably . Conclusion In contrast to ITT analysis , efficacy of rectal EcN application was significant in PP and points to EcN as a well tolerated treatment alternative in moderate distal UC.Trial registration German Clinical Trials Register DRK00000234 In a prospect i ve , r and omized double-blind trial , the efficacy of whole gut irrigation as preoperative bowel preparation for elective colorectal surgery was evaluated alone and in combination with two antimicrobial agents in 148 patients . The antimicrobial regimens were metronidazole alone or metronidazole and ampicillin administered systemically preoperatively and continued for 3 days . Whole gut irrigation was completed without any discomfort in 87 percent of the patients . In 3 percent , the irrigation was stopped and the patients were excluded from the study . Abdominal wound infection developed in 32 percent of the patients after whole gut irrigation , and the addition of metronidazole decreased this incidence to 22 percent ( not significant ) . The incidence in wound infections in the group receiving metronidazole as well as ampicillin was 2 percent , and this difference was highly significant compared with both other groups . No significant difference was found for the incidence of intraabdominal abscesses ( p = 0.06 ) , infection of the perineal wound , or anastomotic leakage . No difference in the postoperative infection rate was found between a bowel containing fecal fluid or fecal masses , but when a bowel was clean , significantly fewer infectious complications were found . Whole gut irrigation is a rapid , well-tolerated , easily performed , and safe form of preoperative bowel preparation in elective colorectal surgery if combined with systemic antimicrobial prophylaxis consisting of antimicrobial agents effective against anaerobic and aerobic organisms Cancer treatment regimens that include radiation therapy ( RT ) to the abdominal region for cervical , ovarian , prostate , sigmoid , or colorectal cancer potentially disturb the colonization resistance of the indigenous gut flora , causing RT-induced diarrhea , enteritis , and colitis in more than 80 % of patients with cancer . One approach for the prevention of RT-induced diarrhea is the use of probiotics . R and omized clinical trials have demonstrated efficacy of probiotic preparations VSL # 3 and Lactobacillus casei DN-114 001 in decreasing the incidence and grade of RT-induced diarrhea . Oncology nurses and advanced practice clinicians are in a position to interpret research findings related to RT-induced diarrhea , enteritis , and colitis and to apply evidence -based practice principles in patients with cancer receiving RT to promote positive outcomes : Although 5‐aminosalicylic acid ( 5‐ASA ) oral compounds are the st and ard maintenance treatment for ulcerative colitis in remission , some patients can not use them because of side‐effects . Clinical and experimental observations have suggested the potential role of probiotics in inflammatory bowel disease therapy We assessed oral 5-aminosalicylic acid ( 5-ASA ) prepared with a pH-sensitive polymer coating in 87 patients with mildly to moderately active ulcerative colitis in a double-blind , placebo-controlled trial . Patients were r and omly assigned to receive 5-ASA at a dosage of either 4.8 or 1.6 g per day or placebo for six weeks . The outcome was monitored by flexible proctosigmoidoscopic examinations and physicians ' assessment s at three-week intervals and by patients ' recordings of daily symptoms . Results showed 24 percent complete and 50 percent partial responses in those receiving 4.8 g of 5-ASA per day as compared with 5 percent complete and 13 percent partial responses in those receiving placebo ( P less than 0.0001 , rank-sum test ) . At a dosage of 1.6 g per day , the response was twice as good as with placebo , but the difference did not reach statistical significance ( P = 0.51 ) . Age , sex , duration of disease , duration of active symptoms , or extent of disease did not affect the clinical outcome . We conclude that oral 5-ASA administered in a dosage of 4.8 g per day is effective therapy , at least in the short term , for mildly to moderately active ulcerative colitis
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 .