Spotlight on VSL#3 Probiotic Mixture in Chronic Inflammatory Bowel Diseases
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VSL#3 (VSL#3®) is a high-concentration probiotic preparation of eight live freeze-dried bacterial species that are normal components of the human gastrointestinal microflora, including four strains of lactobacilli (Lactoba-cillus casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), three strains of bifidobacteria (Bifidobacterium longum, B. breve, and B. infantis), and Streptococcus salivarius subsp. thermophilus.
Data from noncomparative trials suggest that VSL#3 has clinical potential in the treatment of active mild to moderate ulcerative colitis and as maintenance therapy for patients with ulcerative colitis in remission. In addition, a randomized, open-label, multicenter trial showed that VSL#3 in combination with low-dose balsalazide (a prodrug of mesalazine [mesalamine; 5-aminosalicylic acid]) was more effective than standard doses of basalazide or mesalazine monotherapy in the treatment of acute mild to moderate ulcerative colitis. Randomized, double-blind, placebo-controlled studies have shown VSL#3 is effective in preventing the onset of acute pouchitis in patients with newly formed surgical pouches, and in maintaining remission following antibacterial treatment of acute pouchitis in patients with a history of refractory or recurrent pouchitis. Treatment guidelines from the US and the UK include VSL#3 as a therapeutic option for the prevention of pouchitis relapse in patients with chronic pouchitis. In general, VSL#3 was well tolerated in clinical trials. Large, well designed, controlled confirmatory clinical trials will further determine the place of VSL#3 in the treatment of ulcerative colitis.
KeywordsUlcerative Colitis Mesalazine Mesalamine Noncomparative Trial Active Ulcerative Colitis
The full text article in Drugs 2006; 66 (10): 1371–87 was reviewed by: R. Bibiloni, Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada; M. Campieri, Department of Internal Medicine and Gastroenterology, Division of Gastroenterology, University of Bologna, Bologna, Italy; R.N. Fedorak, Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada; P. Gionchetti, Department of Internal Medicine and Gastroenterology, Division of Gastroenterology, University of Bologna, Bologna, Italy; N. Martins, Department of Gastroenterology, University of Massachusetts Medical School, UMass Memorial Health Care, Worcester, Massachusetts, USA; T. Mimura, Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan; M. Schultz, Department of Medical and Surgical Sciences, University of Otago, Dunedin, New Zealand; A. Tursi, Digestive Endoscopy Unit, Lorenzo Bonomo Hospital, Andria, Italy.
- 1.VSL Pharmaceuticals Inc. VSL#3: the living shield [online]. Available from URL: http://www.vsl3.com [Accessed 2005 Nov 4]