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 - PubMed (original) (raw)

Randomized Controlled Trial

. 2010 Oct;105(10):2218-27.

doi: 10.1038/ajg.2010.218. Epub 2010 Jun 1.

Giovanni Brandimarte, Alfredo Papa, Andrea Giglio, Walter Elisei, Gian Marco Giorgetti, Giacomo Forti, Sergio Morini, Cesare Hassan, Maria Antonietta Pistoia, Maria Ester Modeo, Stefano Rodino', Teresa D'Amico, Ladislava Sebkova, Natale Sacca', Emilio Di Giulio, Francesco Luzza, Maria Imeneo, Tiziana Larussa, Salvatore Di Rosa, Vito Annese, Silvio Danese, Antonio Gasbarrini

Affiliations

Free PMC article

Randomized Controlled Trial

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

Antonio Tursi et al. Am J Gastroenterol. 2010 Oct.

Free PMC article

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 randomly 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.

PubMed Disclaimer

Figures

Figure 1

Figure 1

Patient disposition.

Figure 2

Figure 2

Percentage of patients with reduction of ulcerative colitis disease activity index (UCDAI) > 50% or of at least three points, and patients in remission at week 8 (on intention-to-treat analysis). n.s., not significant.

Figure 3

Figure 3

Percentage of patients with improvement in different subgroups of ulcerative colitis disease activity index (UCDAI; rectal bleeding, stool frequency, physician rating of disease activity, and endoscopic score) at week 8 (on intention-to-treat analysis). n.s., not significant.

Comment in

Similar articles

Cited by

References

    1. Schwartz M, Cohen R. Optimizing conventional therapy for inflammatory bowel disease. Curr Gastroenterol Rep. 2008;10:585–590. - PubMed
    1. Travis S, Stange EF, Lémann M, et al. For the European Crohn's and Colitis Organisation (ECCO). European evidence-based consensus of the management of ulcerative colitis: current management. J Crohn Colitis. 2008;2:24–62. - PubMed
    1. Gionchetti P, Rizzello F, Venturi A, et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. Gastroenterology. 2000;119:305–309. - PubMed
    1. Gionchetti P, Rizzello F, Helwig U, et al. Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003;124:1202–1209. - PubMed
    1. Tursi A, Brandimarte G, Giorgetti GM, et al. 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. Med Sci Monit. 2004;10:PI126–PI131. - PubMed

Publication types

MeSH terms

Substances

LinkOut - more resources