1 Sanders ME. Probiotics: Considerations for human health. Nutr Rev. 2003;61(3):91-99.
2 Saarela M, et al. Safety aspects of Lactobacillus and Bifidobacterium species originating from human gastrointestinal tract or from probiotic products. Microb Ecol Health Dis. 2002;14:233-240.
3 Borriello et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003;36(6):775-780.
4 Horowitz S. Promoting gut health with probiotics. Living medicines for treating digestive disorders. Altern Complement Ther. 2003;9(5):219-224.
5 Reuter G. The Lactobacillus and Bifidobacterium microflora of the human intestine: Composition and succession. Curr Issues Intest Microbiol. 2001;2(2):43-53
6 Mountzouris K, et al. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002;87(5):405-420.
7 Holzapfel WH, et al. Overview of gut flora and probiotics. Int J Food Microbiol. 1998;41(2):85-101
8 McNaught CE, et al. Probiotics in clinical practice: A critical review of the evidence. Nutr Res. 2001;21(1&2):343-353
9 Heller F, et al. Intestinal flora and mucosal immune responses. Int J Med Microbiol. 2003;293(1):77-86
10 Fabia R, et al. Impairment of bacterial flora in human ulcerative colitis and experimental colitis in the rat. Digestion.
11 Shaw K, et al. Dysbiosis, inflammation, and response to treatment a longitudinal study of pediatric subjects with newly diagnosed inflammatory bowel disease. Genome Medicine. 2016; 8-75
12 Bullock, et al. Comparative composition of bacteria in the human intestinal microflora during remission and active ulcerative colitis. Curr Issues Intest Microbiol. 2004;5:59-64.
13 Balsari, et al. The faecal microbial population in the irritable bowel syndrome. Microbiologica. 1982;5(3):185-194.
14 Madden and Hunter. A review of the role of the gut microflora in irritable bowel syndrome and the effects of probiotics. Br J Nutr. 2002;88 (Suppl.1):S67-S72.
15 Malinen, et al. Analysis of the fecal microbiota of irritable bowel syndrome patients and health controls with real-time PCR. Am J Gastroenterol. 2005;100(2):373-82.
16 Haque T, et al. Intestinal microbiota in liver disease. Best Practice & Research Clinical Gastroenterology 30 (2016) 133-142
17 Rai R, et al. Gut Microbiota: Its Role in Hepatic Encephalopathy. Journal of Clinical and Experiential Hepatology. 2015 Mar;5(Suppl 1):S29-36.
18 Bajaj et al. Linkage of gut microbiome with cognition in hepatic encephalopathy. Am J Physiol Gastrointest Liver Physiol. 2012 Jan; 302(1) G168–G175.
19 Mimemura and Shimizu. Gut microbiota and liver disease. World J Gastroenterol. 2015 Feb 14 21(6) 1691-1702
20 Sung et al. Microbiota-based treatments in alcoholic liver disease. World J Gastroenterol 2016 August 7 22(29) 6673-6682
21 Llorente C and Schbabl B. The Gut Microbiota and Liver Disease. Cell Mol Gastroenterol Hepatol 2015 1 275-284
22 Camilleri, M. Probiotics and Irritable Bowel Syndrome: Rationale, Putative Mechanisms, and Evidence of Clinical Efficacy. J Clin Gastroenterol 2006;40:264-269
23 Korpela R, et al. Probiotics and irritable bowel syndrome. Microbial Ecology in Health and Disease. 2013. 23 18573
24 Chio et al. Alteration of Gut Microbiotia and Efficacy of Probiotics in Functional Constipation. J Neurogastroenterol Motil. Vol. 21 2093-0879 2015
25 Zandg et al. Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria a meta-analysis. BMC Gastroenterology 2016; 16 64.
26 Fedorak R. Probiotics in the Management of Inflammatory Bowel Diseases? Am J Gastroenterol 2007; 102:S22-S58.
27 Tursi A, et al. Low-dose balsalazide plus 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;10:126-131.
28 Misra et al. Integrative Therapies and Pediatric Inflammatory Bowel Disease The Current Evidence. Children 2014, 1, 149-165
29 Chibbar et al. Probiotics in the Management of Ulcerative Colitis. J Clin Gastroenterol. Vol 49, Supp. 1 2015
30 Shen et al. Effect of Probiotics on Inducing Remission and Maintaining Therapy in UC, Crohn’s Disease and Pouchitis Meta-analysis of Randomized Controlled Trials 2013 2
31 Gionchetti P, et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: A double-blind, placebo-controlled trial. Gastroenterology. 2000;119(2):305-309.
32 Gionchetti P, et al. Prophylaxis of pouchitis onset with probiotic therapy: A double-blind, placebo-controlled trial. Gastroenterology. 2003b;124(5):1202-1209.
33 Singh et al. Treatment and prevention of pouchitis after ileal pouch anastomosis for chronic ulcerative colitis. The Cochrane Collaboration. 2015
34 Kornbluth, et al. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Committee. Am J Gastroenterol. 2010; Mar;105(3):501-23.
35 Hoffmann JC, et al. Diagnosis and therapy of ulcerative colitis: results of an evidence based consensus conference by the German Society of Digestive and Metabolic Diseases and the competence network on inflammatory bowel disease. Z Gastroenterol. 2004;42:979-983.
36 Mowat C, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011. May 60(5) 571-607
37 Biancone L, et al. European evidence-based Consensus on the management of ulcerative colitis: Special situations. J. Crohns Colitis. (2008) 2, 63-92
38 Holubar SD, et al. Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis (Review). Cochrane Database of Systematic Reviews. 2010, Issue 6. Art. No.: CD001176. DOI: 10.1002/14651858.CD001176. pub2.
39 Saab S. et al. Probiotics are helpful in hepatic encephalopathy: a meta-analysis of randomized trials. Liver International. 2015
40 Agrawal A. et al., Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open-Label, Randomized Controlled Trial of Lactulose, Probiotics, and No Therapy. American Journal of Gastroenterology. 2012
41 Mittal, V.V. et al, A randomized controlled trial comparing lactulose, probiotics, and L-ornithine L-aspartate in treatment of minimal hepatic encephalopathy. European Journal of Gastroenterology and Hepatology. 2011
42 Lunia MK, et al. Probiotics prevent hepatic encephalopathy in patients with cirrhosis: a randomized controlled trial. Clin Gastroenterol Hepatol. 2014 Jun;12(6):1003- 8
43 Misra, et al. Integrative Therapies and Pediatric Inflammatory Bowel Disease: The Current Evidence. Children 2014, 1, 149-165.
44 Didari, T et al. Effectiveness of probiotics in irritable bowel syndrome- Updated systematic review with meta-analysis. World J of Gastroenterology 2015 21(10) 3072- 3084
In addition to the above-referenced studies ExeGi takes the position that studies performed on VSL#3®️* are also relevant to the evaluation the efficacy and safety of Visbiome. A list of such studies is available upon request.
*VSL#3®️ is a registered trademark of, and is manufactured exclusively for, VSL Pharmaceuticals, Inc. Visbiome is manufactured exclusively for ExeGi Pharma, LLC and is not affiliated with, endorsed by, or distributed by VSL Pharmaceuticals, Inc.