"Studies of VSL#3 have been conducted in several animal models of colitis and
inflammatory liver disease.33-38 In experimental animal models of colitis, there are
serious derangements in epithelial permeability and barrier function, causing the
animals to be particularly vulnerable to bacterial translocation and inflammatory
immune responses. Collectively, these studies demonstrate that VSL#3 may
normalize gut permeability and barrier function and that it is associated with
beneficial anti-inflammatory and immunomodulatory properties.39-41"
"37. Li Z, et al. Probiotics and antibiotics to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003; 37:343-350."
35. Di Giacinto C. Probiotic administration induces IL-10 and ameliorates inflammation in recurrent TNBS colitis. Presented at: Digestive Disease Week; May 17-22, 2003; Orlando, Fla.
from the informational leaflet for
"VSL#3® JUNIOR A medical food for the dietary management of Irritable Bowel Syndrome (IBS) and Ulcerative colitis (UC) Description VSL#3 JUNIOR is a medical food intended for the dietary management of irritable bowel syndrome (IBS) 1-3 and ulcerative colitis (UC) 4-7. VSL#3 is a probiotic consisting of 8 strains of live, lactic acid bacteria. Each packet contains at least 225 billion lyophilized bacteria. Directions VSL#3 JUNIOR (Watermelon flavor)"
http://www.vsl3.com/pdf/VSL3junior-PI.pdf
Precautions Please keep this product out of reach of children. Pregnant or lactating women should consult with a physician or healthcare professional before using this or any other medical food product. Clinical Experience VSL#3 JUNIOR has been the subject of extensive clinical research in the dietary management of IBS and UC. In one IBS study1 , the consumption of VSL#3 was significantly superior to placebo (p < 0.05) in the primary endpoint, the subjective assessment of relief of symptoms; as well as in 3 of 4 secondary endpoints: abdominal pain/discomfort (p < 0.05), abdominal bloating/gassiness (p < 0.05), and family assessment of life disruption (p < 0.01). No significant difference was found (p < 0.06) in the stool pattern. No untoward adverse effect was recorded in any of the patients. Published studies4, 5 have suggested that daily ingestion of VSL#3 JUNIOR can aid in the dietary management of UC. The first study looked at the induction and maintenance of remission in children aged between 2 and 16, with ulcerative colitis. All 29 patients responded to the inflammatory bowel disease (IBD) induction therapy. Remission was achieved in 13 children (92.8%) treated with VSL#3 and IBD therapy and in 4 children (36.4%) treated with placebo and IBD therapy (P<0.001). Overall, 3 of 14 (21.4%) children treated with VSL#3 and IBD therapy and 11 of 15 (73.3%) children treated with placebo and IBD therapy relapsed within 1 year of follow-up (P=0.014; RR=0.32; CI=0.025-0.773; NNT=2). Of the relapsed children, all 3 children treated with VSL#3 and 6 of 11 (54.5%) children treated with placebo relapsed within 6 months of diagnosis. At 6 months, 12 months, or at time of relapse, endoscopic and histological scores were significantly lower in the VSL#3 group than in the placebo group (P<0.05). There were no biochemical or clinical adverse events related to VSL#3. In the second study, 13 of 18 children completed 8 weeks of VSL#3 treatment and 5 patients were withdrawn due to lack of improvement. Remission (defined as SCCAI ≤ 3) was achieved in 56% of children (n = 10); response (decrease in SCCAI ≥ 2, but final score ≤ 5) in 6% (n = 1); and no change or worsening in 39% (n = 7). Post-VSL#3 treatments demonstrated a bacterial taxonomy change in rectal biopsy. The VSL#3 was well tolerated in clinical trials and no biochemical and clinical adverse effects attributed to VSL#3 were identified. Recommended Daily Intake (depends on age) Detailed Daily Intake for Children (Each JUNIOR packet = 225 CFU) For children, the amount consumed per day varied by age, weight and clinical study.1, 4-5 Storage VSL#3 JUNIOR should be refrigerated (36-46°F or 2-8°C). If stored under refrigeration, the product is guaranteed through “Best if used by” date. VSL#3 JUNIOR can be stored at room temperature for up to two weeks without adversely affecting potency. Dairy Status Some dairy ingredients are used in the culture medium but are removed during manufacturing. There might be trace amounts present at very low levels. For this reason VSL#3 is not defined as a dairy-free product but as a non-dairy product. Gluten Status VSL#3 JUNIOR is gluten free. Kosher Status VSL#3 is Kosher and Halal certified. VSL#3® JUNIOR A medical food for the dietary management of Irritable Bowel Syndrome (IBS) and Ulcerative colitis (UC) Description VSL#3 JUNIOR is a medical food intended for the dietary management of irritable bowel syndrome (IBS) 1-3 and ulcerative colitis (UC) 4-7. VSL#3 is a probiotic consisting of 8 strains of live, lactic acid bacteria. Each packet contains at least 225 billion lyophilized bacteria. Directions VSL#3 JUNIOR (Watermelon flavor) Consume 1 - 4 packets (225 billion to 900 billion bacteria) daily or as directed by your physician. VSL#3 JUNIOR can be mixed into cold drinks such as water and juice or foods like applesauce or ice-cream and consumed. Adjustment of the intestinal flora can take a few days or weeks; it may take up to one month for the colonization of the gut to become optimally stable. Ingredients Active ingredients (the proprietary strains of bacteria) - Streptococcus thermophilus - Bifidobacterium breve - Bifidobacterium longum - Bifidobacterium infantis - Lactobacillus acidophilus - Lactobacillus plantarum - Lactobacillus paracasei - Lactobacillus delbrueckii subsp. bulgaricus Inactive ingredients: Maltose, watermelon flavor, rebiana (stevia) and silicon dioxide. Medical Food As a medical food, VSL#3 JUNIOR is specially formulated and processed to provide a precise mixture of certain bacterial species with potential synergistic relationships. The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized.9-12 Several studies demonstrate that patients with IBS, and UC may have decreased luminal concentrations of lactobacilli and bifidobacteria compared with healthy individuals.13-18 Patients with IBS and UC may benefit from consuming high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. This is particularly important for patients with UC in view of their frequent and often long-term antibiotic treatment. Recent evidence has also implicated harmful intestinal bacteria in the development of inflammatory bowel diseases and IBS.19, 20 Hence, IBS and UC patients may have a distinct nutritional requirement that differs from normal individuals. Daily consumption of high levels of probiotic bacteria is needed to maintain adequate and balanced colonization in the gastrointestinal tract, and this cannot be achieved simply by modification of the normal diet. VSL#3 JUNIOR is intended for use only by IBS or UC patients under the care of a physician. Drug Interactions Avoid taking with antibiotics. Some antibiotics may inactivate certain strains of bacteria in VSL#3 JUNIOR Side Effects Mild abdominal bloating has been reported in the first few days of consuming VSL#3 For the dietary management of Packets per day Pediatric IBS 1-4 Pediatric UC 1-4 Active Pediatric UC 4-8 Recommended intake by age (in years) Dietary Management of active ulcerative colitis (flaring) Dietary Management of ulcerative colitis (maintenance) Dietary Management of IBS Less than 2 years 1/2 to 1 packet per day (open & add to soft food or beverages) 1/2 packet per day (open & add to soft food or beverages) 1/2 packet per day (open & add to soft food or beverages) 2-5 years 1 packet per day (open & add to soft food or beverages) 1 packet per day (open & add to soft food or beverages) 1/2 to 1 packet per day (open & add to soft food or beverages) 6-11 years 2-4 packets per day 1-2 packets per day 1-2 packets per day 12-17 years 4-8 packets per day 2-4 packets per day 1-4 packets per day Safety Probiotics have generally been associated with a long history of safe use.23-25 In fact, many probiotic species are integral to the production of fermented foods and have been consumed safely as part of these foods for millennia.12 Furthermore, many bifidobacteria and lactobacilli species are normal, nonpathogenic inhabitants of the human gastrointestinal tract, oral cavity, skin, and vagina.12,24,26,27 While, theoretically, probiotic species could act as opportunistic pathogens, epidemiological surveillance data indicate that the risk of infection from consumption of lactobacilli is negligible.23,28 In the available literature, documented cases of infection attributable to probiotic treatment are rare and limited to case reports. These case reports are primarily associated with patients having compromised immune systems or other major health problems.29-32 Each strain of probiotic bacteria in VSL#3 is non-pathogenic and non-toxigenic. Studies of VSL#3 have been conducted in several animal models of colitis and inflammatory liver disease.33-38 In experimental animal models of colitis, there are serious derangements in epithelial permeability and barrier function, causing the animals to be particularly vulnerable to bacterial translocation and inflammatory immune responses. Collectively, these studies demonstrate that VSL#3 may normalize gut permeability and barrier function and that it is associated with beneficial anti-inflammatory and immunomodulatory properties.39-41 The probiotics contained within VSL#3 do not translocate from the gut lumen or act opportunistically when ingested by animals suffering from colitis. How Supplied References 1. Guandalini et al. VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. J Pediatr Gastroenterol Nutr. 2010 51(1): 24-30. 2. Kim et al. A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2003; 17:895-904. The sponsored research clinical trials were conducted at the Mayo Clinic College of Medicine, Rochester, MN. 3. 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. The sponsored research clinical trials were conducted at the Mayo Clinic College of Medicine, Rochester, MN. 4. Miele et al. Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol. 2009; 104(2): 4437-443. 5. Huynh et al. Probiotic preparation VSL#3 induces remission in children with mild to moderate acute ulcerative colitis: a pilot study. Inflamm Bowel Dis. 2009; 15(5): 760-768. 6. Bibiloni et al. VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis. Am J Gastroenterol. 2005; 100:1539-1546. 7. Venturi A, et al. Impact on the composition of the faecal flora by a new probiotic preparation: Preliminary data on maintenance treatment of patients with ulcerative colitis. Aliment Pharmacol Ther. 1999; 13 (8):1103-1108. 8. 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. 9. Holzapfel WH, et al. Overview of gut flora and probiotics. Int J Food Microbiol. 1998; 41(2): 85-101. 10. McNaught CE, MacFie J. Probiotics in clinical practice: A critical review of the evidence. Nutr Res. 2001; 21(1&2):343-353. 11. Heller F, Duchmann R. Intestinal flora and mucosal immune responses. Int J Med Microbiol. 2003; 293(1):77-86. 12. Sanders ME. Probiotics: Considerations for human health. Nutr Rev. 2003; 61(3):91-99. 13. Fabia R, et al. Impairment of bacterial flora in human ulcerative colitis and experimental colitis in the rat. Digestion. 1993; 54(4):248-255. 14. Ruseler-van Embden JG, et al. Inability of Lactobacillus casei strain GG, L. acidophilus, and Bifidobacterium bifidum to degrade intestinal mucus glycoproteins. Scand J Gastroenterol. 30(7):675-680. 15. 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. 16. 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. 17. 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. 18. Kerckhoffs AP et al. Lower Bifidobacteria counts in both duodenal mucosa-associated and fecal microbiota in irritable bowel syndrome patients. World J Gastroenterol. 2009 Jun 21;15(23):2887-92 19. Whelan K. Probiotics and prebiotics in the management of irritable bowel syndrome: a review of recent clinical trials and systematic reviews. Curr Opin Clin Nutr Metab Care. 2011 Nov; 14(6):581-7. 20. Gurudu S, et al. Inflammatory bowel disease. Best Pract Res Clin Gastroenterol. 2002; 16(1): 77-90. 21. Kornbluth et al. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Committee. Am J Gastroenterol. 2004; 99(7):1371-1385. 22. 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. 23. Saarela M, et al. Safety aspects of Lactobacillus and Bifidobacterium species originating from human oro-gastrointestinal tract or from probiotic products. Microb Ecol Health Dis. 2002; 14:233-240. 24. Borriello et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003; 36(6):775-780. 25. Horowitz S. Promoting gut health with probiotics. Living medicines for treating digestive disorders. Altern Complement Ther. 2003; 9(5):219-224. 26. Reuter G. The Lactobacillus and Bifidobacterium microflora of the human intestine: Composition and succession. Curr Issues Intest Microbiol. 2001; 2(2):43-53. 27. Mountzouris K, et al. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002; 87(5):405-420. 28. Saxelin M, et al. Lactobacilli and bacteremia in southern Finland, 1989-1992. Clin Infect Dis. 1996a; 22(3):564-566. 29. Oggioni MR, et al. Recurrent septicemia in an immunocompromised patient due to probiotic strains of Bacillus subtilis. J Clin Microbiol. 1998; 36 (1):325-326. 30. Mackay AD, et al. Lactobacillus endocarditis caused by a probiotic organism. Clin Microbiol Infect. 1999; 5(5):290-292. 31. Rautio M, et al. Liver abscess due to a Lactobacillus rhamnosus strain indistinguishable from L. rhamnosus strain GG. Clin Infect Dis. 1999; 28(5):1159-1160. 32. Marteau PR. Probiotics in clinical conditions. Clin Rev Allergy Immunol. 2002; 22(3):255-273. 33. Soper P, et al. Oral administration of VSL#3 in restoring epithelial ion transport and barrier function in IL-10-/- mice. Presented at: Digestive Disease Week; May 2001; Atlanta, Ga. 34. Shibolet O, et al. Variable response to probiotics in two models of experimental colitis in rats. Inflamm Bowel Dis. 2002; 8(6):399-406. 35. Di Giacinto C. Probiotic administration induces IL-10 and ameliorates inflammation in recurrent TNBS colitis. Presented at: Digestive Disease Week; May 17-22, 2003; Orlando, Fla. 36. Endersby R, et al. Probiotic bacteria attenuate pro-inflammatory cytokine secretion and maintain colonic permeability in a murine model of sepsis. Presented at: Digestive Disease Week; May 17-22, 2003; Orlando, Fla. 37. Li Z, et al. Probiotics and antibiotics to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003; 37:343-350. 38. Jijon H, et al. DNA from probiotic bacteria modulates murine and human epithelial and immune function. Gastroenterology. In press. 39. Madsen K, et al. Probiotic bacteria enhance murine and human intestinal epithelial barrier function. Gastroenterology. 2001; 121:580-591. 40. Hart et al. Modulation of human dendritic cell phenotype and function by probiotic bacteria. Gut. 2004; 53:1602-1609. 41. Pertof EO, et al. Probiotics inhibit nuclear factor-kB and induce heat shock proteins in colonic epithelial cells. Gastroenterology. 2004; 127:1474-1487. UPC Size 7-45749-01536-5 30 Watermelon flavored packets per box Distributed by Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878 ©2012 Sigma-Tau Pharmaceuticals, Inc. All Rights Reserved Made in the USA V1122 06/12
"37. Li Z, et al. Probiotics and antibiotics to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003; 37:343-350."
35. Di Giacinto C. Probiotic administration induces IL-10 and ameliorates inflammation in recurrent TNBS colitis. Presented at: Digestive Disease Week; May 17-22, 2003; Orlando, Fla.
from the informational leaflet for
"VSL#3® JUNIOR A medical food for the dietary management of Irritable Bowel Syndrome (IBS) and Ulcerative colitis (UC) Description VSL#3 JUNIOR is a medical food intended for the dietary management of irritable bowel syndrome (IBS) 1-3 and ulcerative colitis (UC) 4-7. VSL#3 is a probiotic consisting of 8 strains of live, lactic acid bacteria. Each packet contains at least 225 billion lyophilized bacteria. Directions VSL#3 JUNIOR (Watermelon flavor)"
http://www.vsl3.com/pdf/VSL3junior-PI.pdf
Precautions Please keep this product out of reach of children. Pregnant or lactating women should consult with a physician or healthcare professional before using this or any other medical food product. Clinical Experience VSL#3 JUNIOR has been the subject of extensive clinical research in the dietary management of IBS and UC. In one IBS study1 , the consumption of VSL#3 was significantly superior to placebo (p < 0.05) in the primary endpoint, the subjective assessment of relief of symptoms; as well as in 3 of 4 secondary endpoints: abdominal pain/discomfort (p < 0.05), abdominal bloating/gassiness (p < 0.05), and family assessment of life disruption (p < 0.01). No significant difference was found (p < 0.06) in the stool pattern. No untoward adverse effect was recorded in any of the patients. Published studies4, 5 have suggested that daily ingestion of VSL#3 JUNIOR can aid in the dietary management of UC. The first study looked at the induction and maintenance of remission in children aged between 2 and 16, with ulcerative colitis. All 29 patients responded to the inflammatory bowel disease (IBD) induction therapy. Remission was achieved in 13 children (92.8%) treated with VSL#3 and IBD therapy and in 4 children (36.4%) treated with placebo and IBD therapy (P<0.001). Overall, 3 of 14 (21.4%) children treated with VSL#3 and IBD therapy and 11 of 15 (73.3%) children treated with placebo and IBD therapy relapsed within 1 year of follow-up (P=0.014; RR=0.32; CI=0.025-0.773; NNT=2). Of the relapsed children, all 3 children treated with VSL#3 and 6 of 11 (54.5%) children treated with placebo relapsed within 6 months of diagnosis. At 6 months, 12 months, or at time of relapse, endoscopic and histological scores were significantly lower in the VSL#3 group than in the placebo group (P<0.05). There were no biochemical or clinical adverse events related to VSL#3. In the second study, 13 of 18 children completed 8 weeks of VSL#3 treatment and 5 patients were withdrawn due to lack of improvement. Remission (defined as SCCAI ≤ 3) was achieved in 56% of children (n = 10); response (decrease in SCCAI ≥ 2, but final score ≤ 5) in 6% (n = 1); and no change or worsening in 39% (n = 7). Post-VSL#3 treatments demonstrated a bacterial taxonomy change in rectal biopsy. The VSL#3 was well tolerated in clinical trials and no biochemical and clinical adverse effects attributed to VSL#3 were identified. Recommended Daily Intake (depends on age) Detailed Daily Intake for Children (Each JUNIOR packet = 225 CFU) For children, the amount consumed per day varied by age, weight and clinical study.1, 4-5 Storage VSL#3 JUNIOR should be refrigerated (36-46°F or 2-8°C). If stored under refrigeration, the product is guaranteed through “Best if used by” date. VSL#3 JUNIOR can be stored at room temperature for up to two weeks without adversely affecting potency. Dairy Status Some dairy ingredients are used in the culture medium but are removed during manufacturing. There might be trace amounts present at very low levels. For this reason VSL#3 is not defined as a dairy-free product but as a non-dairy product. Gluten Status VSL#3 JUNIOR is gluten free. Kosher Status VSL#3 is Kosher and Halal certified. VSL#3® JUNIOR A medical food for the dietary management of Irritable Bowel Syndrome (IBS) and Ulcerative colitis (UC) Description VSL#3 JUNIOR is a medical food intended for the dietary management of irritable bowel syndrome (IBS) 1-3 and ulcerative colitis (UC) 4-7. VSL#3 is a probiotic consisting of 8 strains of live, lactic acid bacteria. Each packet contains at least 225 billion lyophilized bacteria. Directions VSL#3 JUNIOR (Watermelon flavor) Consume 1 - 4 packets (225 billion to 900 billion bacteria) daily or as directed by your physician. VSL#3 JUNIOR can be mixed into cold drinks such as water and juice or foods like applesauce or ice-cream and consumed. Adjustment of the intestinal flora can take a few days or weeks; it may take up to one month for the colonization of the gut to become optimally stable. Ingredients Active ingredients (the proprietary strains of bacteria) - Streptococcus thermophilus - Bifidobacterium breve - Bifidobacterium longum - Bifidobacterium infantis - Lactobacillus acidophilus - Lactobacillus plantarum - Lactobacillus paracasei - Lactobacillus delbrueckii subsp. bulgaricus Inactive ingredients: Maltose, watermelon flavor, rebiana (stevia) and silicon dioxide. Medical Food As a medical food, VSL#3 JUNIOR is specially formulated and processed to provide a precise mixture of certain bacterial species with potential synergistic relationships. The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized.9-12 Several studies demonstrate that patients with IBS, and UC may have decreased luminal concentrations of lactobacilli and bifidobacteria compared with healthy individuals.13-18 Patients with IBS and UC may benefit from consuming high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. This is particularly important for patients with UC in view of their frequent and often long-term antibiotic treatment. Recent evidence has also implicated harmful intestinal bacteria in the development of inflammatory bowel diseases and IBS.19, 20 Hence, IBS and UC patients may have a distinct nutritional requirement that differs from normal individuals. Daily consumption of high levels of probiotic bacteria is needed to maintain adequate and balanced colonization in the gastrointestinal tract, and this cannot be achieved simply by modification of the normal diet. VSL#3 JUNIOR is intended for use only by IBS or UC patients under the care of a physician. Drug Interactions Avoid taking with antibiotics. Some antibiotics may inactivate certain strains of bacteria in VSL#3 JUNIOR Side Effects Mild abdominal bloating has been reported in the first few days of consuming VSL#3 For the dietary management of Packets per day Pediatric IBS 1-4 Pediatric UC 1-4 Active Pediatric UC 4-8 Recommended intake by age (in years) Dietary Management of active ulcerative colitis (flaring) Dietary Management of ulcerative colitis (maintenance) Dietary Management of IBS Less than 2 years 1/2 to 1 packet per day (open & add to soft food or beverages) 1/2 packet per day (open & add to soft food or beverages) 1/2 packet per day (open & add to soft food or beverages) 2-5 years 1 packet per day (open & add to soft food or beverages) 1 packet per day (open & add to soft food or beverages) 1/2 to 1 packet per day (open & add to soft food or beverages) 6-11 years 2-4 packets per day 1-2 packets per day 1-2 packets per day 12-17 years 4-8 packets per day 2-4 packets per day 1-4 packets per day Safety Probiotics have generally been associated with a long history of safe use.23-25 In fact, many probiotic species are integral to the production of fermented foods and have been consumed safely as part of these foods for millennia.12 Furthermore, many bifidobacteria and lactobacilli species are normal, nonpathogenic inhabitants of the human gastrointestinal tract, oral cavity, skin, and vagina.12,24,26,27 While, theoretically, probiotic species could act as opportunistic pathogens, epidemiological surveillance data indicate that the risk of infection from consumption of lactobacilli is negligible.23,28 In the available literature, documented cases of infection attributable to probiotic treatment are rare and limited to case reports. These case reports are primarily associated with patients having compromised immune systems or other major health problems.29-32 Each strain of probiotic bacteria in VSL#3 is non-pathogenic and non-toxigenic. Studies of VSL#3 have been conducted in several animal models of colitis and inflammatory liver disease.33-38 In experimental animal models of colitis, there are serious derangements in epithelial permeability and barrier function, causing the animals to be particularly vulnerable to bacterial translocation and inflammatory immune responses. Collectively, these studies demonstrate that VSL#3 may normalize gut permeability and barrier function and that it is associated with beneficial anti-inflammatory and immunomodulatory properties.39-41 The probiotics contained within VSL#3 do not translocate from the gut lumen or act opportunistically when ingested by animals suffering from colitis. How Supplied References 1. Guandalini et al. VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. J Pediatr Gastroenterol Nutr. 2010 51(1): 24-30. 2. Kim et al. A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2003; 17:895-904. The sponsored research clinical trials were conducted at the Mayo Clinic College of Medicine, Rochester, MN. 3. 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. The sponsored research clinical trials were conducted at the Mayo Clinic College of Medicine, Rochester, MN. 4. Miele et al. Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol. 2009; 104(2): 4437-443. 5. Huynh et al. Probiotic preparation VSL#3 induces remission in children with mild to moderate acute ulcerative colitis: a pilot study. Inflamm Bowel Dis. 2009; 15(5): 760-768. 6. Bibiloni et al. VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis. Am J Gastroenterol. 2005; 100:1539-1546. 7. Venturi A, et al. Impact on the composition of the faecal flora by a new probiotic preparation: Preliminary data on maintenance treatment of patients with ulcerative colitis. Aliment Pharmacol Ther. 1999; 13 (8):1103-1108. 8. 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. 9. Holzapfel WH, et al. Overview of gut flora and probiotics. Int J Food Microbiol. 1998; 41(2): 85-101. 10. McNaught CE, MacFie J. Probiotics in clinical practice: A critical review of the evidence. Nutr Res. 2001; 21(1&2):343-353. 11. Heller F, Duchmann R. Intestinal flora and mucosal immune responses. Int J Med Microbiol. 2003; 293(1):77-86. 12. Sanders ME. Probiotics: Considerations for human health. Nutr Rev. 2003; 61(3):91-99. 13. Fabia R, et al. Impairment of bacterial flora in human ulcerative colitis and experimental colitis in the rat. Digestion. 1993; 54(4):248-255. 14. Ruseler-van Embden JG, et al. Inability of Lactobacillus casei strain GG, L. acidophilus, and Bifidobacterium bifidum to degrade intestinal mucus glycoproteins. Scand J Gastroenterol. 30(7):675-680. 15. 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. 16. 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. 17. 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. 18. Kerckhoffs AP et al. Lower Bifidobacteria counts in both duodenal mucosa-associated and fecal microbiota in irritable bowel syndrome patients. World J Gastroenterol. 2009 Jun 21;15(23):2887-92 19. Whelan K. Probiotics and prebiotics in the management of irritable bowel syndrome: a review of recent clinical trials and systematic reviews. Curr Opin Clin Nutr Metab Care. 2011 Nov; 14(6):581-7. 20. Gurudu S, et al. Inflammatory bowel disease. Best Pract Res Clin Gastroenterol. 2002; 16(1): 77-90. 21. Kornbluth et al. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Committee. Am J Gastroenterol. 2004; 99(7):1371-1385. 22. 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. 23. Saarela M, et al. Safety aspects of Lactobacillus and Bifidobacterium species originating from human oro-gastrointestinal tract or from probiotic products. Microb Ecol Health Dis. 2002; 14:233-240. 24. Borriello et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003; 36(6):775-780. 25. Horowitz S. Promoting gut health with probiotics. Living medicines for treating digestive disorders. Altern Complement Ther. 2003; 9(5):219-224. 26. Reuter G. The Lactobacillus and Bifidobacterium microflora of the human intestine: Composition and succession. Curr Issues Intest Microbiol. 2001; 2(2):43-53. 27. Mountzouris K, et al. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002; 87(5):405-420. 28. Saxelin M, et al. Lactobacilli and bacteremia in southern Finland, 1989-1992. Clin Infect Dis. 1996a; 22(3):564-566. 29. Oggioni MR, et al. Recurrent septicemia in an immunocompromised patient due to probiotic strains of Bacillus subtilis. J Clin Microbiol. 1998; 36 (1):325-326. 30. Mackay AD, et al. Lactobacillus endocarditis caused by a probiotic organism. Clin Microbiol Infect. 1999; 5(5):290-292. 31. Rautio M, et al. Liver abscess due to a Lactobacillus rhamnosus strain indistinguishable from L. rhamnosus strain GG. Clin Infect Dis. 1999; 28(5):1159-1160. 32. Marteau PR. Probiotics in clinical conditions. Clin Rev Allergy Immunol. 2002; 22(3):255-273. 33. Soper P, et al. Oral administration of VSL#3 in restoring epithelial ion transport and barrier function in IL-10-/- mice. Presented at: Digestive Disease Week; May 2001; Atlanta, Ga. 34. Shibolet O, et al. 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