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. Prophylaxis of pouchitis onset with probiotic therapy: A double‐blind, placebo‐controlled trial Probiotic Therapy of the Irritable Bowel Syndrome: Why Is the Evidence Still Poor and What Can Be Done About It? A pilot trial of Saccharomyces boulardii in ulcerative colitis The prophylactic use of probiotics in the prevention of radiation therapy-induced diarrhea. Efficacy of probiotic treatment with Bifidobacterium longum 536 for induction of remission in active ulcerative colitis: A randomized, double-blinded, placebo-controlled multicenter trial. Double‐blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis Probiotic VSL#3 reduces liver disease severity and hospitalization in patients with cirrhosis: a randomized, controlled trial. Colon Cleansing for Colonoscopy in Patients with Ulcerative Colitis: Efficacy and Acceptability of a 2-L PEG Plus Bisacodyl Versus 4-L PEG Sources of evidence for systematic reviews of interventions in diabetes. The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease. Beneficial Effects of Probiotic Bifidobacterium and Galacto-Oligosaccharide in Patients with Ulcerative Colitis: A Randomized Controlled Study Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Olsalazine versus mesalazine in the treatment of mild to moderate ulcerative colitis Comparison of omega-3 fatty acids and sulfasalazine in ulcerative colitis. Impact on the composition of the faecal flora by a new probiotic preparation: preliminary data on maintenance treatment of patients with ulcerative colitis The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Delayed-Release Oral Mesalamine at 4.8 g/day (800 mg tablet) for the Treatment of Moderately Active Ulcerative Colitis: The ASCEND II 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 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 Despite numerous r and omized clinical trials and meta-analyses , there is no increased evidence for the efficacy of  probiotics  in the treatment of irritable bowel syndrome ( IBS ) . We review this evidence , identify and analyse the reasons for this lack of evidence and propose method ological improvements for future studies . Methods Based on a literature search , we identified 56 papers that matched the purpose of our analyses . Twenty-seven studies used multi-species bacterial preparations and 29 used single-strain probiotics . They were analysed regarding  patients included , treatment duration , probiotic dosage , and outcome measures . Results Trials in both groups suffered from heterogeneity with respect to probiotic concentration , duration of treatment , and other method ological issues ( crossover design and underpowered studies ) . This heterogeneity did not allow the application of a meta-analytic approach and a systematic review was therefore performed instead . Multi-strain preparations combined 2 to 8 different bacterial subspecies , mostly lactobacilli or bifidobacteria , and used variable lengths of treatments . Overall , more than 50 % of trials presented negative outcomes . The majority of the single-strain probiotic trials employing lactobacilli or Saccharomyces were negative , whereas trials employing bifidobacteria showed positive results . Conclusions The heterogeneity of the studies of probiotics in IBS questions the value of meta-analyses . The use of different bacterial strains and different mixtures of these strains , as well as different dosages , are the main contributors to this heterogeneity . Current data provides limited evidence for the efficacy of a small number of  single-strain probiotics  in IBS ( mostly bifidobacteria ) and sound studies following strict trial guidelines ( Food and Drug Administration and European Medicines Agency guidelines for clinical trials ) are needed . We summarised and proposed some method ological issues for future studies in the field Objectives Probiotics can be useful in the treatment of inflammatory bowel disease . In a previous report , the non-pathogenic yeast Saccharomyces boulardii was found to be beneficial in the maintenance treatment of Crohn 's disease . The aim of this study was to assess the efficacy of S. boulardii in ulcerative colitis patients . Methods A group of 25 patients with a mild to moderate clinical flare-up of ulcerative colitis received additional treatment with S. boulardii 250 mg three times a day for 4 weeks during maintenance treatment with mesalazine . These patients were unsuitable for steroid therapy . Before and after treatment , Rachmilewitz 's clinical activity index was calculated . The probiotic treatment was considered a therapeutic success only when the final score was lower than 6 . Results Of the 24 patients who completed the study , 17 attained clinical remission ; this was confirmed endoscopically . Conclusions Our preliminary results suggest that S. boulardii can be effective in the treatment of ulcerative colitis . Controlled studies with this probiotic agent are warranted 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 BACKGROUND AND AIM We conducted a r and omized , double-blinded , placebo-controlled trial to investigate the efficacy of Bifidobacterium longum 536 ( BB536 ) supplementation for induction of remission in Japanese patients with active ulcerative colitis ( UC ) . METHODS Fifty-six patients with mild to moderate UC were enrolled . Three patients had pancolitis , 36 had left-sided colitis , and 17 had proctitis . Patients were r and omly treated with 2 - 3 × 10(11 ) freeze-dried viable BB536 ( 28 patients ) or placebo ( 28 patients ) for 8 weeks . RESULTS In total , 63 % of patients receiving BB536  showed clinical remission ( UC disease activity index [ UCDAI ] ≤2 ) at week 8 compared to 52 % of those receiving placebo ( P = 0.395 ) . We observed a significant decrease of UCDAI scores ( 3.8 ± 0.4 at baseline to 2.6 ± 0.4 at week 8) in the BB536 group ( P < 0.01 ) , whereas there was no significant decrease in the placebo group ( P = 0.88 ) . There was also a significant decrease in the Rachmilewitz endoscopic index ( EI ) and the Mayo subscore at week 8 in the BB536 group , whereas there was no significant decrease in the placebo group . A single patient in the BB536 group complained of a mild side-effect , but no other adverse effects were observed . CONCLUSION Supplementation with BB536 was well tolerated and reduced UCDAI scores , EI and Mayo subscores after 8 weeks in Japanese patients with mild to moderately active UC 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 Little is known about whether probiotics can affect outcomes of patients with cirrhosis and hepatic encephalopathy ( HE ) . We assessed the efficacy of a probiotic preparation in preventing the recurrence of HE ( primary outcome ) and reducing the number of hospitalizations and severity of liver disease in patients with cirrhosis . METHODS We performed a double-blind trial at a tertiary care hospital in India . Patients with cirrhosis who had recovered from an episode of HE during the previous month were assigned r and omly ( using computer-generated allocation ) to groups given a probiotic preparation ( VSL#3 , 9 × 10(11 ) bacteria ; CD Pharma India Private Limited , New Delhi , India ) ( n = 66 ) or placebo ( n = 64 ) daily for 6 months . RESULTS There was a trend toward a reduction in the development of breakthrough HE among patients receiving the probiotic ( 34.8 % in the probiotic group vs 51.6 % in the placebo group ; hazard ratio [ HR ] , 0.65 ; 95 % confidence interval [ CI ] , 0.38 - 1.11 ; P = .12 ) . Fewer patients in the probiotic group were hospitalized for HE ( 19.7 % vs 42.2 % , respectively ; HR , 0.45 ; 95 % CI , 0.23 - 0.87 ; P = .02 ) or for complications of cirrhosis ( 24.2 % ) than in the placebo group ( 45.3 % ) ( HR , 0.52 ; 95 % CI , 0.28 - 0.95 ; P = .034 ) . Child-Turcotte-Pugh and model for end-stage liver disease scores improved significantly from baseline to 6 months in the probiotic group , but not in the placebo group . There were no adverse events related to VSL#3 . CONCLUSIONS Over a 6-month period , daily intake of VSL#3 significantly reduced the risk of hospitalization for HE , as well as Child-Turcotte-Pugh and model for end-stage liver disease scores , in patients with cirrhosis . Clinical Trials.gov number : NCT01110447 Background : Low-volume preparations are gaining attention for higher acceptability but have been never evaluated in IBD . We compare the efficacy , safety , and tolerability of a 2-L PEG with a 4-L PEG solution in patients with ulcerative colitis . Methods : This is a multicenter , r and omized , single-blind study . Adult out patients with ulcerative colitis undergoing colonoscopy received either 2-L PEG plus bisacodyl or 4-L PEG . Bowel cleansing was assessed using the Ottawa Scale and rated as adequate if the score was ⩽2 in each colon segment . Patient acceptance , satisfaction , and related symptoms were recorded . Results : Preparation was adequate in 80 % of the 211 patients without any differences between groups . Mean Ottawa scores for whole and right colon were similar in the 2 groups . As concern tolerability , 83 % patients in 2-L PEG arm and 44.8 % in 4-L PEG arm reported no or mild discomfort ( P < 0.0001 ) and 94.3 % and 61.9 % expressed their willingness to repeat the preparation ( P < 0.001 ) . Palatability was better with 2-L PEG , whereas related symptoms occurred more frequently with 4-L PEG . Regardless of preparation , split dosage was associated with better cleansing . Further predictors of poor cleansing were moderate/severe discomfort during preparation and more than 6 hours between end of preparation and colonoscopy . Extension and severity of colitis did not influence quality of preparation . Conclusions : Low-volume PEG is not inferior to 4-L PEG for bowel cleansing in ulcerative colitis , but it is better tolerated and accepted . The time interval from solution intake and colonoscopy is the most important factor affecting quality of cleansing in ulcerative colitis AIMS To analyse the effect on systematic review s in diabetes interventions of including only trials that are indexed in medline , and to assess the impact of adding trials from other data bases and the grey literature . METHODS All systematic review s of diabetes interventions which included a meta- analysis of r and omized controlled trials , and were published since 1996 , were selected . The impact on the meta- analysis of including only those trials indexed in medline , and the effect of then adding trials from other sources , was assessed . Where possible this was measured quantitatively , by redoing the meta- analysis , otherwise a qualitative estimate was made . RESULTS Forty-four systematic review s met our inclusion criteria . There were 120 articles reporting trial data which were not indexed in medline . These came from 52 % of the review s. In 34 % of the review s , basing a meta- analysis on a search of only medline would miss trials that could affect the result . Sources of non- medline data which had the biggest effect on the meta-analyses were journal articles from central and embase ( mainly in Diabetes , Nutrition and Metabolism ) and unpublished data ( mainly from industry ) . The exceptions were journal articles on herbal medicine , mostly indexed in Chinese language data bases . CONCLUSIONS A search of only the medline data base is insufficient for systematic review s of diabetes , because in about 34 % of review s the missed trials could affect the results of the meta- analysis . It is recommended that central ( on the Cochrane Library ) also be search ed . Scanning meeting abstract s , and seeking unpublished data are also recommended if the intervention has only recently been introduced 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 / Aim : In previous studies , we described the beneficial effects of bifidobacteria-fermented milk in patients with ulcerative colitis ( UC ) . Here , we examined the effects of a live Bifidobacterium breve strain Yakult , a probiotic contained in bifidobacteria-fermented milk , and galacto-oligosaccharide ( GOS ) as synbiotics in UC patients . Methods : Forty-one patients with mild to moderate UC were assigned to two groups ; one group was treated with the synbiotics and the other was not ( control ) . The treatment group ingested 1 g of the probiotic powder ( 109 CFU/g ) three times a day , and 5.5 g of GOS once a day for one year . At the start and the end of this study , colonoscopic index and the amount of myeloperoxidase in a lavage solution were used as disease activity indices . Bacterial counts in the feces at the start and the end of this study were also examined . Results : After a one-year treatment with the synbiotics , the clinical status of the UC patients as assessed by colonoscopy , significantly improved . Furthermore , the amount of myeloperoxidase in the lavage also decreased in these patients after the synbiotic treatment . The synbiotics significantly reduced the fecal counts of Bacteroidaceae and fecal pH. Conclusion : Administration of live B. breve strain Yakult and GOS can improve the clinical condition of patients with UC . These results encouraged us to perform a large-scale r and omized , placebo-controlled trial BACKGROUND & AIMS SPD476 ( MMX mesalamine ) , a novel , once-daily mesalamine formulation , uses MMX Multi Matrix System ( MMX ) technology to delay and extend delivery of active drug throughout the colon . We performed a r and omized , double-blind , parallel-group , placebo-controlled , multicenter phase III study in patients with mild to moderately active ulcerative colitis . METHODS Two hundred eighty patients with mild to moderately active ulcerative colitis received MMX mesalamine 2.4 g/day given twice daily ( n = 93 ) , 4.8 g/day given once daily ( n = 94 ) , or placebo ( n = 93 ) for 8 weeks . The primary end point was the percentage of patients in clinical and endoscopic remission ( modified ulcerative colitis disease activity index score of < or = 1 , with a score of 0 for rectal bleeding and stool frequency , and at least a 1-point reduction in sigmoidoscopy score ) at week 8 . Patients with mucosal friability were not considered to have achieved this end point . RESULTS Clinical and endoscopic remission at week 8 was achieved by 34.1 % and 29.2 % of patients receiving MMX mesalamine 2.4 g/day given twice daily and MMX mesalamine 4.8 g/day given once daily , respectively , versus 12.9 % receiving placebo ( P < .01 ) . MMX mesalamine was generally well-tolerated . CONCLUSIONS MMX mesalamine given once or twice daily is well-tolerated and , compared with placebo , demonstrated efficacy for the induction of clinical and endoscopic remission in mild to moderately active ulcerative colitis To compare the efficacy and tolerability of olsalazine sodium with enteric‐coated mesalazine in inducing endoscopic remission in patients with mild to moderate active ulcerative colitis Fish oil omega-3 fatty acids exert antiinflammatory effects on patients with ulcerative colitis . However , a comparative study in patients with mild to moderate ulcerative colitis receiving only sulfasalazine or omega-3 fatty acids has not been performed . We sought to detect changes in the inflammatory disease activity with the use of either fish oil omega-3 fatty acids or sulfasalazine in patients with ulcerative colitis . Ten patients ( five male , five female ; mean age = 48 + /- 12 y ) with mild to moderate active ulcerative colitis were investigated in a r and omized cross-over design . They received either sulfasalazine ( 2 g/d ) or omega-3 fatty acids ( 5.4 g/d ) for 2 m.o . Disease activity was assessed by clinical and laboratory indicators , sigmoidoscopy , histology , and whole-body protein turnover ( with 15N-glycine ) . Treatment with omega-3 fatty acids result ed in greater disease activity as detected by a significant increase in platelet count , erythrocyte sedimentation rate , C-reactive protein , and total fecal nitrogen excretion . No major changes in protein synthesis and breakdown were observed during either treatment . In conclusion , treatment with sulfasalazine is superior to treatment with omega-3 fatty acids in patients with mild to moderate active ulcerative colitis : 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 BACKGROUND & AIMS Interobserver differences in endoscopic assessment s contribute to variations in rates of response to placebo in ulcerative colitis ( UC ) trials . We investigated whether central ized review of images could reduce these variations . METHODS We performed a 10-week , r and omized , double-blind , placebo-controlled study of 281 patients with mildly to moderately active UC , defined by an Ulcerative Colitis Disease Activity Index ( UCDAI ) sigmoidoscopy score ≥2 , that evaluated the efficacy of delayed-release mesalamine ( Asacol 800-mg tablet ) 4.8 g/day . Endoscopic images were review ed by a single expert central reader . The primary outcome was clinical remission ( UCDAI , stool frequency and bleeding scores of 0 , and no fecal urgency ) at week 6 . RESULTS The primary outcome was achieved by 30.0 % of patients treated with mesalamine and 20.6 % of those given placebo , a difference of 9.4 % ( 95 % confidence interval [ CI ] , -0.7 % to 19.4 % ; P = .069 ) . Significant differences in results from secondary analyses indicated the efficacy of mesalamine . Thirty-one percent of participants , all of whom had a UCDAI sigmoidoscopy score ≥2 as read by the site investigator , were considered ineligible by the central reader . After exclusion of these patients , the remission rates were 29.0 % and 13.8 % in the mesalamine and placebo groups , respectively ( difference of 15 % ; 95 % CI , 3.5%-26.0 % ; P = .011 ) . CONCLUSIONS Although mesalamine 4.8 g/day was not statistically different from placebo for induction of remission in patients with mildly to moderately active UC , based on an intent-to-treat analysis , the totality of the data supports a benefit of treatment . Central review of endoscopic images is critical to the conduct of induction studies in UC ; Clinical Trials.gov Number , NCT01059344 BACKGROUND AND AIMS : Preliminary data have shown that delayed release oral mesalamine ( Asacol ® ) dosed at 4.8 g/day provided additional efficacy benefit compared to 1.6 g/day in patients with mildly to moderately active ulcerative colitis . Additionally , Asacol dosed at 2.4 g/day has been proved to be more effective than 1.6 g/day . Whether 4.8 g/day of mesalamine ( dosed with an investigational 800 mg tablet ) is more effective than Asacol 2.4 g/day ( dosed with a 400 mg tablet ) in patients with moderately active ulcerative colitis is unknown . METHODS : A r and omized , double-blind , controlled trial ( ASCEND II ) was conducted to evaluate the efficacy of 4.8 g/day of mesalamine in adults with active ulcerative colitis . Three hundred eighty-six patients with mild to moderate ulcerative colitis were r and omized for treatment with mesalamine 2.4 g/day ( 400 mg tablet ) or 4.8 g/day ( 800 mg tablet ) for 6 wk . The primary efficacy population was 268 patients with moderately active ulcerative colitis treated with 2.4 g/day ( n = 139 ) or 4.8 g/day ( n = 129 ) . The primary endpoint was the proportion of patients in each treatment group that achieved overall improvement ( “ treatment success , ” defined as either complete remission or a clinical response to therapy ) from baseline at week 6 . RESULTS : Seventy-two percent of patients receiving 4.8 g/day of mesalamine for moderate ulcerative colitis ( 89/124 patients ) achieved treatment success at week 6 , compared with 59 % of those who received 2.4 g/day ( 77/130 patients ) ( p = 0.036 ) . Both regimens were well tolerated . Adverse events and clinical ly significant changes in laboratory results were similar in both treatment groups . CONCLUSIONS : Patients with moderately active ulcerative colitis treated with 4.8 g/day of mesalamine ( 800 mg tablet ) are significantly more likely to achieve overall improvement at 6 wk compared to patients treated with 2.4 g/day
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 .