Original article—alimentary tractThe Probiotic Preparation, VSL#3 Induces Remission in Patients With Mild-to-Moderately Active Ulcerative Colitis
Section snippets
Design
This was a multicenter, double-blind, placebo-controlled, randomized trial. The study was conducted at 3 tertiary care centers in North India between June 2005 and August 2007.
Participants
Adult patients (>18 y) who had mild-to-moderately active UC (Ulcerative Colitis Disease Activity Index [UCDAI] score, 3–9; with minimum sigmoidoscopic score of 2) extending for more than 15 cm from the anal verge with at least one previously documented attack of active disease were included in this study. None of the
Sample Size
The sample size was based on a power of 80% and a statistical significance (alpha) of 95% (P = .05). This assumed that a response to treatment at 12 weeks, such as with oral mesalamine preparations, was expected to occur in 65% of patients treated with VSL#3 compared with 40% treated with placebo (ie, an expected difference of 25%). This assumed that the probiotic is as effective as oral mesalamine. Hence, 70 patients were required in each group with an additional 10% for drop-outs, therefore
Participant Flow
Of 187 patients screened for inclusion in the study, 40 could not be included (18 did not meet inclusion criteria, 12 were excluded, and 10 refused to participate). A total of 147 patients were randomized; 77 received VSL#3 and 70 received placebo (Supplementary Figure 1). Fifty-five patients in the VSL#3 group and 29 patients in the placebo group completed the entire study. Among the 22 patients who withdrew from the VSL#3 group, 17 had worsening of symptoms and 5 were lost to follow-up
Discussion
This was a multicenter, randomized, double-blind, placebo-controlled trial evaluating the role of the probiotic cocktail VSL#3 for treatment of mild-to-moderately active UC. The addition of VSL#3 to conventional treatment resulted in significantly higher clinical response and remission rates. Moreover, VSL#3 therapy significantly decreased the frequency of stools and rectal bleeding, resulting in overall improvement in participant well-being.
There are a few studies that have shown the
Acknowledgments
The authors express their gratitude to Professor Richard Fedorak of the University of Alberta (Edmonton, Alberta, Canada) for giving useful advice in finalizing the manuscript, and to CD Pharma (New Delhi) for providing the research grant as well as the VSL#3 and placebo for the study. The authors sincerely acknowledge the contribution of Mr Aditya R. Sahu for helping them in the conduct of the study, data analysis, and manuscript preparation.
The clinical trial is registered with Clinical Trial
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Conflicts of interest The authors disclose no conflicts.
Funding This study was supported by CD Pharma India Private, Ltd, New Delhi, India.