References

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 Kim et al. A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating. Neurogastroenterol Motil (2005) 17,1-10

23 Kim et al. A randomized controlled trial of a probiotic, VSL#3, on gut transitand symptoms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther 2003; 17:895-904

24 Chio et al. Alteration of Gut Microbiotia and Efficacy of Probiotics in Functional Constipation. J Neurogastroenterol Motil. Vol. 21 2093-0879 2015

25 Wong et al. Melatonin Regulation as a Possible Mechanism for Probiotic (VSL#3) in Irritable Bowel Syndrome: A Randomized Double-Blinded Placebo Study. Dig Dis Sci. 2014

26 Bibiloni et al. VSL#3* Probiotic-Mixture Induces Remission in Patients with Active Ulcerative Colitis. Am J Gastroenterology 2005;100:1539-1546

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 Huynh et al. Probiotic Preparation VSL#3* Induces Remission in Children with Mild to Moderate Acute Ulcerative Colitis: A Pilot Study. Inflam Bowel Dis. 2008

29 Sood et al. The Probiotic Preparation, VSL#3* Induces Remission in Patients with Mild to Moderately Active Ulcerative Colitis. Clinical Gastroenterology and Hepatology 2009;7:1202-1209

30 Tursi, et al. Treatment of Relapsing Mild-to-Moderate Ulcerative Colitis With the Probiotic VSL # 3 as Adjunctive to a Standard Pharmaceutical Treatment: A Double-Blind, Randomized, Placebo-Controlled Study. American Journal Of Gastro. 2010

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 Mimura et al. Once daily high dose probiotic therapy (VSL#3*) for maintaining remission in recurrent or refractory pouchitis. Gut 2004; 53: 108-114

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 Dhiman et al. Probiotic VSL#3* Reduces Liver Disease Severity and Hospitalization in Patients With Cirrhosis: A Randomized Controlled Trial. Gastroenterology. 2014;147:1327-1337

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 Guandalini et al. VSL#3 Improves Symptoms in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Crossover Study. JPNG. 2010;51: 24-30

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In addition to the above-referenced studies ExeGi takes the position that studies performed on VSL#3®️* as produced before January 31, 2016, are also relevant to the evaluation the efficacy and safety of Visbiome.

*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. 

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