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scientific evidence

VSL#3 probably has more scientific evidence to back up its use than any other poly-biotic

There is a wealth of clinical data for VSL#3 in a number of different conditions including:

Pouchitis

Author Title Reference
Pronio A Probiotic administration in patients with ileal pouch-anal anastomosis for ulcerative colitis is associated with expansion of mucosal regulatory cells. Inflamm Bowel Dis. 2008;14:662-8.
Kuhbacher T Bacterial and fungal microbiota in relation to probiotic therapy (VSL#3) in pouchitis. Gut. 2006;55:833-41.
Shen B Maintenance therapy with a probiotic in antibiotic-dependent pouchitis: experience in clinical practise. Aliment Pharmacol Ther. 2005;22:721-8.
Mimura T Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis. Gut. 2004;53:108-14.
Gionchetti P Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003;124:1202-9.
Gionchetti P Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. Gastroenterology. 2000;119:305-9.
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Irritable Bowel Syndrome (IBS)

Author Title Reference
Wong Melatonin regulation as a possible mechanism for probiotic (VSL#3) in irritable bowel syndrome: a randomized double-blinded placebo study. Dig Dis Sci. 2015;60(1):186-94. doi: 10.1007/s10620-01403299-8. Epub 2014 Aug 5.
Vicari E Chronic bacterial prostatis and irritable bowel syndrome: effectiveness of treatment with rifaximin followed by the probiotic VSL#3. Asian J Androl. 2014;16(5):735-9. doi:10.4103/1008-682X. 131064.
De Boer VSL#3&#174 a Probiotic combination, reduces the severity of abdominal pain and bloating and improves quality of life in irritable bowel syndrome (IBS): data from a multi-centre, prospective, observational study. Digestive Diseases and Sciences. 5 August 2014.
Ng S Effect of probiotic bacteria on the intestinal microbiota in irritable bowel syndrome. J Gastroenterol Hepatol. 2013;28(10):1624-31. doi:10.1111/jgh.12306.
Michail S and Kenche H Gut microbiota is not modified by randomized, double-blind, placebo-controlled trial of VSL#3 in diarrhoea-predominant irritable bowel syndrome. Probiotics & Antimicro. Prot. 2011;3:1-7.
Parkes G The probiotic VSL#3 increases SCBM and reduces symptom severity scores in patients with functional constipation. Gut. 2011;60(Suppl 1) Abstract
Guandalini S Efficacy of probiotic VSL#3 in children with irritable bowel syndrome with bloating. An international, randomized, placebo-controlled, double-blind, cross-over trial. Journal of Paed Gastro and Nutrition. 2010;51(1):24-30.
Kim H A randomized controlled trial of a probiotic combination VSL#3 and placebo in irritable bowel syndrome with bloating. Neurogastroenterol Motil. 2005;17:687-96.
Kim H A randomized controlled trial of a probiotic, VSL#3, on gut transit Aliment Pharmacol Ther. 2003;17:895-904.
Bazzocchi G Intestinal microflora and oral bacteriotherapy in irritable bowel syndrome. Digest Liver Dis. 2002;34 (Suppl 2):S48-53.
Brigidi P Effects of probiotic administration upon the composition and enzymatic activity of human fecal microbiota in patients with irritable bowel syndrome or functional diarrhoea. Res. Microbiol. 2001;152:735-41.
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Crohn's disease

Author Title Reference
Fedorak R et al. The probiotic VSL#3 has anti-inflammatory Effects and could reduce endoscopic recurrence After surgery for Crohn’s disease. Clinical Gastroenterology and Hepatology. November 2014. doi:10.1016/j.cgh.2014.10.031
De Smet S Could adjuvant therapy with VSL#3 be effective pediatric Crohn’s disease type L1? An open pilot report. P186/22.BWG 2013 IBD BIRD – BeSPGHAN Abstract
Day A et al. The probiotic VSL#3 in children with Crohn’s disease in Remission. Gastroenterology. 2012;142(5 Suppl 1):S-377.
Day A et al. The probiotic VSL#3 in children with active Crohn disease. Gastroenterology. 2012;142(5 Suppl 1): S-378.
Madsen K A randomized controlled trial of VSL#3 for the prevention of endoscopic recurrence following surgery for Crohn’s Disease. Gastroenterology. 2008;134(Suppl 1):A361 Abstract
Roghati S A randomized trial evaluating probiotic preparation VSL#3 versus oral mesalamine. Gastroenterology Vol. 2008;134(4 Suppl 1):A-712 Abstract
Campieri M Mesalamine in patients with active microscopic colitis. Gastroenterology. 2000;118:A4179.
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Inflammatory Bowel Disease

Author Title Reference
Cruchet S et al. The use of probiotics in pediatric gastroenterology: a review of the literature and recommendations by latin-american experts Paediatr Drugs. 2015 Jun;17(3):199-216. doi:10.1007/s40272-015-0124-6.
S. Guandalini, E. Cernat and D. Moscoso Prebiotics and probiotics in irritable bowel syndrome and inflammatory bowel disease in children. Beneticial Microbes. 2014;12:1-9.
Shen J et al. Effect of probiotics on inducing remission and maintaining therapy in ulcerative colitis, Crohn’s disease, and pouchitis: meta-analysis of randomized controlled trials. Inflamm Bowel Dis. 2014;20(1):21-35.
Yezaz A Ghouri et al. Systematic review of randomized controlled trials of probiotics, and synbiotics in inflammatory bowel disease. Clinical and Experimental Gastroenterology. 2014;7:473-87.
Bemstein C Antibiotics, probiotics and prebiotics in IBD. Nestle Nutr Inst Workshop Ser. 2014;79:83-100. doi:10.1159/000360713. Epub 2014 Sep 5.
Mardini H Probiotic mix VSL#3 is effective adjunctive therapy for mild to moderately active ulcerative colitis: a meta-analysis. Inflammatory Bowel Disease. 2014;20(9):1562-1567.
Jonkers D Probiotics in the management of inflammatory bowel disease: a systematic review of intervention studies in adult patients. Drugs. 2012;16:72(6):803-23. doi:10.2165/11632710-000000000-00000.
Williams M Probiotics as therapy in gastroenterology: a study of physician opinions and recommendations. J Clin Gastroenterol. 2010;44(9):631-6. doi:10.1097/ MCG.0b013e3181d47f5b.
Cary V What is the evidence for the use of probiotics in the treatment of inflammatory bowel disease? J Clin Nurs. 2010;19(7-8):904-16. doi:10.111/j-1365-2702.2009.03123.x.
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Diarrhoea

Author Title Reference
Zaharoni H Probiotics improve bowel movements in hospitalized elderly patients – The PROAGE study J Nutr Health Aging. 2011;15(3):215-20.
Frohmader T Decrease in frequency of liquid stool in enterally fed critically ill patients given the multispecies probiotic VSL#3: a pilot trial. Am J Crit Care. 2010;19(3):e1-11.
Dubey A Use of VSL#3 in the treatment of rotavirus diarrhoea in children. J Clin Gastroenterol. 2008;42(Suppl 3):S126-9.
Selinger C Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial. J Hosp Infect 2013;84(2):159-65. doi:10.1016/j.jhin.2013.02.019. E pub 2013 Apr 22.
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Paediatrics

Author Title Reference
Alisi A Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2014;39(11):1276-85. doi:10.1111/apt.12758. Epub 2014 Apr 16.
M Baldassarre et al. PS-054 VSL#3 Supplementation to Mothers during feeding improves colics and regurgitation in newborns, perhaps by Tgf-b modulation. Arch Dis Child. 2014;99:A131-2.
Guandalini S Efficacy of the probiotic VSL#3 in children with irritable bowel syndrome. An international, randomized, placebo-controlled, double-blind, cross-over trial. Journal of Paed Gastro and Nutrition. 2010;51:24-30.
Huynh H Probiotic preparation VSL#3 induces remission in children with mild to moderate acute ulcerative colitis: a pilot study. Inflamm Bowel Dis. 2009;15:760-8.
Miele E Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol. 2009;104:437-43.
Dubey A Use of VSL#3 in the treatment of rotavirus diarrhoea in children. J Clin Gastroenterol. 2008;42(Suppl 3):S126-9.
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and many others...

1. Madsen K et al. Gastroenterology 2001;121(3):580-91.    2. Guarner FG & Malagelada Lancet 2003;361:512-9.
3. Pagini C et al. PNAS 2010;107(1):454-9.

Healthcare professional information

HEALTHCARE PROFESSIONAL INFORMATION

1. Chapman T et al. Drugs 2006;66(10):1371-87.
2. Data on File, Ferring UK Ltd.
3. Kim HJ et al. Aliment Pharmacol Ther 2003;17:895-904.
4. Kim HJ et al. Neurogastroentero Motil 2005;17:687-696.
5. Wong. Dig Dis Sci. 2015 Jan; 60. 2014.

Due to the European Food Safety Authority (EFSA) rulings regarding the use of the terminology "probiotic", we now refer to VSL#3 as a poly-biotic which highlights its combination of 8 different strains and 450 billion bacteria.

VL/1215/2016/UKa

July 2016

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VL/1366/2014/UK(1)