VSL#3 Capsules
Product Overview
Brand: VSL Pharmaceuticals
Barcode: 7 45749 01781 9
Net Contents: 60 Capsule(s)
Serving Size (Overview): 2 Capsule(s) [containing 225 billion bacteria]
Product Type: Other Combinations [A1325]
Form: Capsule [E0159]
Date Entered: May 24, 2017
Market Status: Off Market
Suggested Use (Overview): Directions: Consume 2-8 capsules daily or as directed by your physician. Recommended Daily Intake1 serving = 2 capsules containing 225 billion bacteriaFor Dietary Management Of Capsules Per DayIrritable Bowel Syndrome1;2 2-4 (225-450 billion)Ulcerative Colitis3-5 4-8 (450-900 billion)
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Eight Strains Of Lactic Acid Bacteria | blend | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Streptococcus thermophilus | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Bifidobacterium breve | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Bifidobacterium longum | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Bifidobacterium infantis | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Lactobacillus acidophilus | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Lactobacillus plantarum | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Lactobacillus paracasei | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Lactobacillus delbrueckii subsp. bulgaricus | bacteria | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Microcrystalline Cellulose | other | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Stearic Acid | fatty acid | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Magnesium Stearate | other | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Vegetable Capsule | other | N/A | N/A | N/A | N/A | 2 Capsule(s) |
| Silicon Dioxide | mineral | N/A | N/A | N/A | N/A | 2 Capsule(s) |
Label Statements
Branding Statement(s)
- The living shield Description: VSL#3 capsules are a medical food which is intended for the dietary management of irritable bowel syndrome (IBS) and ulcerative colitis (UC). VSL#3 is a probiotic consisting of 8 strains of live freeze-dried lactic acid bacteria. VSL#3 and The Living Shield are trademarks of VSL Pharmaceuticals Inc. US Patent # US RE 40023E and other Patents Pending.2012. As a medical food VSL#3 is specially formulated and processed to provide a precise mixture of certain bacterial species with potential synergistic relationships. VSL#3 Capsules are intended for use only by IBS or UC patients under the care of a physician. Clinical ExperienceVSL#3 Capsules (reported as VSL#3) has been the subject of extensive clinical research in the dietary management of IBS or UC. The consumption of VSL#3 has been shown to be effective in the management of gas and bloating associated with IBS in two placebo-controlled randomized trials conducted at the Mayo Clinic.12 In one study the consumption of VSL#3 reduced bloating by 39% in patients with diarrhea-predominant IBS.1 In the same study fecal urgency scores showed a trend toward reduction vs placebo. In a second study the consumption of VSL#3 reduced flatulence (gas) by 25% vs placebo.2 In both IBS studies the consumption of VSL#3 was well tolerated with no adverse events reported. In a study evaluating the efficacy of VSL#3 consumption in UC patients intolerant or allergic to 5-ASA 75% of patients maintained remission for 12 months.5
Other
- A medical food for the dietary management of irritable bowel syndrome or ulcerative colitis that is intended to be used under the supervision of a physician Made in the USA. All rights reserved. The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized. 6-9 Several studies demonstrate that patients with IBS or UC may have decreased luminal concentrations of lactobacilli and bifidobacteria compared with normal individuals.10-15 Hence IBS and UC patients may have a distinct nutritional requirement that differs from normal individuals. Daily consumption of extremely high levels of probiotic bacteria which cannot be achieved simply by modification of the normal diet is needed to maintain adequate and balanced colonization in the gastrointestinal tract in these patients. Patients with IBS or UC may therefore benefit from consuming high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. SafetyProbiotics have generally been associated with a long history of safe use.16-18 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. 18 Furthermore many bifidobacteria and lactobacilli species are normal nonpathogenic inhabitants of the human gastrointestinal tract oral cavity skin and vagina. 919-21 While theoretically probiotic species may act as opportunistic pathogens epidemiological surveillance data indicate that the risk of infection from consumption of lactobacilli is negligible. 2223 In the available literature documented cases of infection attributable to probiotic treatment are extremely rare and limited to a few individual case reports. 24-27 Each strain of probiotic bacteria is nonpathogenic and nontoxigenic. An independent panel of food safety experts concluded that VSL#3 is Generally Recognized As Safe (GRAS) for medical food use How SuppliedVSL#3 Capsules is supplied as an encapsulated powder. References: 1. Kim HJ Camilleri M McKinzie S 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 Minn.2. Kim HJ Vazquez Roque MI Camilleri M 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 Minn.3. Bibiloni R Fedorak RN et al. VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis. Am J Gastroenterol. 2005;100:1539-1546.4. 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):1103-1108.5. 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;10:126-131.6. Holzapfel WH et al. Overview of gut flora and probiotics. Int J Food Microbiol. 1998;41(2):85-101.7. McNaught CE MacFie J. Probiotics in clinical practice: A critical review of the evidence. Nutr Res. 2001; 21(1&2):343-353. 8. Heller F Duchmann R. Intestinal flora and mucosal immune responses. Int J Med Microbiol. 2003; 293(1):77-86.9. Sanders ME. Probiotics: Considerations for human health. Nutr Rev. 2003;61(3):91-99. 10. Fabia R et al. Impairment of bacterial flora in human ulcerative colitis and experimental colitis in the rat. Digestion. 1993;54(4):248-255. 11. 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):675-680.12. 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 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 100(2):373-382.16. Saarela M et al. Safety aspects of Lactobacillus and Bifidobacterium species originating from human orogastrointestinal tract or from probiotic products. Microb Ecol Health Dis. 2002;14:233-240.17. Borriello et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003; 36(6):775-780.18. Horowitz S. Promoting gut health with probiotics. Living medicines for treating digestive disorders. Altern Complement Ther. 2003;9(5):219-224.19. Reuter G. The Lactobacillus and Bifidobacterium microflora of the human intestine: Composition and succession. Curr Issues Intest Microbiol. 2001;2(2):43-53.20. Mountzouris K et al. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002;87(5):405-420.21. Borriello et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003; 36(6):775-780.22. Saxelin M et al. Lactobacilli and bacteremia in southern Finland 1989-1992. Clin Infect Dis. 1996a; 22(3):564-566.23. Saarela M et al. Safety aspects of Lactobacillus and Bifidobacterium species originating from human orogastrointestinal tract or from probiotic products. Microb Ecol Health Dis. 2002;14:233-240.24. Oggioni MR et al. Recurrent septicemia in an immunocompromised patient due to probiotic strains of Bacillus subtilis. J Clin Microbiol. 1998;36(1):325-328.25. Mackay AD et al. Lactobacillus endocarditis caused by a probiotic organism. Clin Microbiol Infect. 1999;5 (5):290-292.26. Rautio M et al. Liver abscess due to a Lactobacillus rhamnosus strain indistinguishable from L. rhamnosus strain GG. Clin Infect Dis. 1999;28(5):1159-1160.27. Marteau PR. Probiotics in clinical conditions. Clin Rev Allergy Immunol. 2002;22(3):255-273. Product of USA. 2011 Sigma-Tau Pharmaceuticals Inc. All rights reserved.
Formulation
- 112.5 billion live lactic acid bacteria per capsule Each serving (2 capsules) contains at least 225 billion lyophilized lactic acid bacteria. Product may contain trace amounts of dairy ingredients at very low levels. Gluten StatusVSL#3 is gluten-free Kosher/Halal StatusVSL#3 is kosher and halal certified. Ingredients: Lactic acid bacteria microcrystalline cellulose stearic acid silicon dioxide magnesium stearate and vegetable capsule (hydroxypropyl methylcellulose). Kosher/Halal Status VSL#3 is kosher and halal certified.
Suggested Use
- Directions: Consume 2-8 capsules daily or as directed by your physician. Recommended Daily Intake1 serving = 2 capsules containing 225 billion bacteriaFor Dietary Management Of Capsules Per DayIrritable Bowel Syndrome12 2-4 (225-450 billion)Ulcerative Colitis3-5 4-8 (450-900 billion)
Precautions
- Do not use if bottle seal is broken or damaged. 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. Some dairy ingredients are used in the culture medium but are removed during manufacturing. Product may contain trace amounts of dairy ingredients at very low levels. Drug InteractionsAvoid taking with antibiotics. Some antibiotics may inactivate certain strains of bacterium in VSL#3. Side EffectsMild abdominal bloating has been reported in the first few days of consuming VSL#3. PrecautionsPlease 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. Dairy StatusSome dairy ingredients are used in the culture medium but are removed during manufacturing. There might be trace amounts at very low levels. For this reason VSL#3 is not defined as a dairy-free product but as a non-dairy product.
Product Specific Information
- StorageVSL#3 Capsules should be refrigerated (39-46(0)F 4-8(0)C). If stored under refrigeration the product is guaranteed through “Best if used by” date. VSL#3 Capsules can be stored at room temperature for up to one week without adversely affecting potency of bacteria.
Product/Version Code
- V1038 03/11
Associated Company Information & Roles
Sigma-Tau Pharmaceuticals
Gaithersburg
20878
MD
Roles for this Product:
- Distributor