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Probiotic Mix VSL#3 Is Effective Adjunctive Therapy for Mild to Moderately Active Ulcerative Colitis: A Meta-analysis

Mardini, Houssam E. MD, MPH*; Grigorian, Alla Y. MD, PhD

doi: 10.1097/MIB.0000000000000084
Original Clinical Articles

Background: VSL#3 is a probiotic mix preparation reported to be effective in the treatment of mild to moderately active ulcerative colitis. We aimed to perform a systematic review of the literature and a meta-analysis of studies on its efficacy.

Methods: The searched databases included PubMed, Scopus, and ScienceDirect. The Mantel–Haenszel method was used to pool the effect- ize across studies, and the odds ratios (ORs) and 95% confidence intervals (CIs) of experiencing a specific outcome were calculated.

Results: Five studies with 441 patients were identified. The pooled remission rate was 49.4% (95% CI, 42.7–56.1). Only 3 low risk of bias studies with 319 patients met the inclusion criteria for further analysis. A total of 162 patients received 3.6 × 1012 CFU/d VSL#3, and 157 patients received placebo. A total of 95% of patients received concomitant therapies with 5-ASA and/or immunomodulators. The Ulcerative Colitis Disease Activity Index was used to define response and remission. A >50% decrease in the Ulcerative Colitis Disease Activity Index was achieved in 44.6% of the VSL#3-treated patients versus 25.1% of the patients given placebo (P = 0008; OR, 2.793; 95% CI, 1.375–5.676; number needed to treat = 4–5). The response rate was 53.4% in VSL#3-treated patients versus 29.3% in patients given placebo (P < 0001; OR, 3.03; 95% CI, 1.89–4.83; number needed to treat = 3–4). The remission rate was 43.8% in VSL#3-treated patients versus 24.8% in patients given placebo (P = 0007; OR, 2.4; 95% CI, 1.48–3.88; number needed to treat = 4–5). No serious side effects were reported.

Conclusions: VSL#3, when added to conventional therapy at a daily dose of 3.6 × 1012 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.

Article first published online 10 June 2014.Supplemental Digital Content is Available in the Text.

*University of Kentucky College of Medicine and Lexington VA Medical Center, Lexington, Kentucky; and

University of Miami, Miller School of Medicine, Miami, Florida.

Reprints: Houssam E. Mardini, MD, MPH, 800 Rose Street, Room MN649, Lexington, KY 40536 (e-mail:

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (

The authors have no conflicts of interest to disclose.

Received April 15, 2014

Accepted April 21, 2014

© Crohn's & Colitis Foundation of America, Inc.
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