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The World Health Organization’s (WHO) 2001 definition of probiotics is “live micro-organisms which, when administered in adequate amounts, confer a health beneﬁt on the host”.1
Probiotics have been shown to exert a wide range of effects.
The term probiotic is derived from the Latin preposition “pro,” which means “for” and the Greek word “biotic” meaning “bios” or “life”.2
The original modern hypothesis of the positive role played by certain bacteria was first introduced by Russian scientist and Nobel laureate Élie Metchnikoff, who in 1907 suggested that it would be possible to modify the gut flora and to replace harmful microbes with useful microbes.3 Metchnikoff proposed the hypothesis that the aging process results from the activity of putrefactive (proteolytic) microbes producing toxic substances in the large bowel. Proteolytic bacteria such as clostridia, which are part of the normal gut flora, produce toxic substances including phenols, indols, and ammonia from the digestion of proteins. According to Metchnikoff, these compounds were responsible for what he called “intestinal autointoxication”, which would cause the physical changes associated with old age.4
Two of the most well-known probiotic bacteria include Lactobacillus and Bifidobacteria, which have been researched in detail.
1 Food and Agriculture Organization and World Health Organization Expert Consultation. Evaluation of health and nutritional properties of powder milk and live lactic acid bacteria. Córdoba, Argentina: Food and Agriculture Organization of the United Nations and World Health Organization; 2001. Available from: ftp://ftp.fao.org/es/esn/food/probio_report_en.pdf. Accessed 2005 September 8.
2 Faujdar, S. S., Mehrishi, P., Bishnoi, S., & Sharma, A. (2016). Role of Probiotics in human health and disease: An update. Int. J. Curr. Microbiol. App. Sci, 5(3), 328-344.
3 Caramia, G. (2003). [Probiotics: from Metchnikoff to the current preventive and therapeutic possibilities]. La Pediatria medica e chirurgica: Medical and surgical pediatrics, 26(1), 19-33.
4 Bested, A. C., Logan, A. C., & Selhub, E. M. (2013). Intestinal microbiota, probiotics and mental health: from Metchnikoff to modern advances: Part II–contemporary contextual research. Gut pathogens, 5(1), 1.
VSL#3 is a combination of live lactic acid bacteria probiotics that have been cultivated, freeze-dried and mixed in a very high concentration (hundreds of billions per gram). It contains 8 different strains of bacteria which have been selected, cultivated in and mixed in proportions in order to optimize the functionality of the product.
VSL#3® is a high potency product which two main characteristics: a very high bacterial concentration and a specific mixture of different bacterial species*. The use of a complex mixture containing exact proportions of different bacterial species promotes the balance of the microbial composition of the intestines through a synergistic action of the different strains.
* See country specific packaging and leaflet of the product
VSL#3 is made up of:
– 4 strains of Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus*)
– 3 strains of Bifidobacteria (B. longum**, B. infantis**, B. breve)
– 1 strain of Streptococcus thermophilus.
* Recently, following genetic investigation, it has been reclassified as L.helveticus.
** Recently, following genetic investigation, it has been demonstrated to belong to the same original strain and reclassified as Bifidobacterium animalis subsp. lactis.
The identity and concentration of each microorganism in VSL#3® are confirmed by examining microscopic morphology, physiologic and biochemical characters and phylogenic properties.
Other ingredients include: maltose, cornstarch, anti-caking agent: silicon dioxide.
VSL#3 should be kept refrigerated (36-46° F or 2-8° C). However, VSL#3 may be stored at room temperature (77° F or 25°C) for up to two weeks without adversely affecting potency. Refrigeration preserves the live bacteria and helps maintain high potency.
VSL#3 has 2 years of shelf life from manufacturing date when stored properly (36-46° F or 2-8° C)
VSL#3 is one of the most potent probiotics in the world. It is 10 times more potent than the average probiotic* (average CFU = 15.5 billion) – that is, according to IRI data 09/12, about 4.3 billion CFU. Each serving of VSL#3® contains from 45 to 900 billion live lactic acid bacteria and bifidobacteria.**
* Information available by searches made by the company worldwide (Reference products, among others, Yovis, Diclofor, Lactoflorene, Florvis, Proflora, Bibiflor, Inuflor, Lactopank, Simbiflor, Biotrap, Brefovil] ; Famularo et.al. Traditional and high potency probiotic preparation for oral bacteriotherapy. BioDrugs 1999; 12(6): 455-470
** See country specific packaging of the product
Only for the US market, VSL#3 is designated for the dietary management of various diseases like ulcerative colitis, irritable bowel syndrome (IBS), pouchitis and others.
Over 140 studies and reviews have been conducted. VSL#3 has a 15 year track record of consistent effectiveness*, making VSL#3 one of the most studied probiotics.
* Data base available at your physician/doctor
WGO (World Gastroenterology Organization Global Guidelines, 2015), suggests the use of VSL#3® in ulcerative colitis (Sood A, Midha V, Makharia GK, Ahuja V, Singal D, Goswami P, et al. The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis. Clin Gastroenterol Hepatol 2009;7:1202–9, 1209.e1.)
IBS is a functional bowel disorder characterized by abdominal pain associated with altered bowel habits and in many cases with abdominal bloating. (Thompson et al., 1999; Hamilton-Miller, 2001; Madden and Hunter, 2002; Tsuchiya et al., 2004; Malinen et al., 2005). Patients with IBS often experience bloating and visible abdominal distension, which may be due to hypersensitivity of the abdominal wall, increased tissue water content, endoluminal fluid accumulation, and increased gas production.
Different studies have shown that VSL#3 retarded colonic transit with no adverse events, reduced the colon’s reflex motor responses to balloon distension and significantly improved abdominal bloating. (Kim H, Vazquez Roque MI, Camilleri M, Stephens D, Burton DD, Baxter K, Thomforde G, Zinsmeister AR, 2005)
Ulcerative colitis is a chronic inflammatory bowel disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus.
Different studies have demonstrated that VSL#3 induced remission in ulcerative colitis. Thanks to the use of VSL#3 there was noticeable improvement in: stool frequency, blood in stool issues, mucosal appearance, and physician’s global assessment in patients with ulcerative colitis.
The most frequent long-term complication experienced by patients who have undergone total proctocolectomy with ileal pouch-anal anastomosis is pouchitis.
Pouchitis is clinically characterized by variable symptoms, including increased stool frequency and fluidity, rectal bleeding, abdominal cramping, urgency, incontinence, fever, and extraintestinal manifestations. Different trials have shown that VSL#3 is beneficial for maintaining remission in patients with pouchitis, for preventing pouchitis.
VSL#3 formulations can be taken every day for as long as needed to eliminate or control problems. The recommended daily intake of VSL#3® is 1 – 4 sachets a day, depending on the underlying condition and age. Most people start with 1 sachet per day for approximately 2 weeks and then adjust as needed.
Whether VSL#3 is consumed by capsule, packet or sachet, it is easy and flexible. It’s important to not mix VSL#3 packets with or take with hot drinks or foods, as the heat can inactivate the bacteria. It’s always necessary to take VSL#3 as recommended by a doctor.
The length of time VSL#3 is consumed depends on the specific reason for which VSL#3 has been recommended. Therefore, it is important to consult with your healthcare provider as to the length of time VSL#3 should be consumed.
VSL#3 can be stored at room temperature (77°F- 25°C) for up to two weeks without having a major effect on potency. If it is left at room temperature for long periods of time or exposed to excessive heat, the number of beneficial bacteria in VSL#3 can become greatly reduced.
If unopened and stored under refrigeration (36-46°F or 2-8°C), VSL#3 products are guaranteed through the “Best if used by” date.
In general, VSL#3 takes up to 1 week to become established in the gut. A study conducted with VSL#3 confirms that maximum bacterial colonization of the gut occurs within 20 days. This high level of colonization remains stable throughout consumption. After daily intake it is interrupted, the strains in VSL#3 will survive in the gut for up to 1 week.
VSL#3 can be mixed in water or any cold, non-carbonated beverage or any cold food such as yogurt, ice cream or apple sauce, and then consumed. VSL#3 and VSL#3-DS should not be mixed with hot beverages or hot foods as high heat inactivates the live bacteria in VSL#3.
Clinical studies that have evaluated VSL#3 for dietary management of ulcerative colitis (UC), pouchitis or irritable bowel syndrome (IBS), used varying daily amounts of VSL#3, from 900 to 3,600 (4 packets of VSL#3-DS) billion bacteria in adults and from 450 to 1800 billion bacteria in children. Please consult with your physician for the recommended daily intake of VSL#3. Daily intake, based on studies performed are as follows, regarding some of our specific formulation:
VSL#3 Packets (450 billion in each): Consume 1-8 packets daily or as directed.
VSL#3 should be consumed for bowel disorder to stabilize the intestinal flora.
Only in USA, VSL#3 may be used also for the dietary management of medically diagnosed ulcerative colitis (UC), pouchitis or irritable bowel syndrome (IBS). However, VSL#3-DS is for the dietary management of pouchitis or UC only.
VSL#3 is a high potency probiotic*. It provides a combination of bacteria which colonize and protect the gastrointestinal (GI) tract with balanced quantities and types of live bacteria . Additional effects of probiotics continue to be described as intensive study is ongoing in this field.
VSL#3 is a high potency probiotic that contains eight different strains of live bacteria that have been carefully cultivated and mixed proportionally to optimize the probiotic content.
VSL#3-DS packets available in USA contain 900 billion beneficial bacteria and require a prescription. VSL#3 packets contain 450 billion bacteria and the VSL#3 capsules contain 112.5 billion beneficial bacteria. VSL#3 packets and capsules are available without a prescription.*
*See country specific packaging and leaflet
VSL#3-DS, available in USA, sachet contains 900 billion good bacteria and requires a prescription. VSL#3 packets contain 450 billion good bacteria. VSL#3 capsules contain 112.5 billion good bacteria per capsule.*
*See country specific packaging
The capsules are made of hydroxypropyl-methylcellulose (HPMC) which is 100% vegetable cellulose and meets the strict dietary needs of consumers that choose a vegetarian lifestyle.
Yes, VSL#3 is gluten free as defined by the proposed FDA definition of a gluten free food (F.R. Jan 23,2007 Vol.72, No.14).
VSL#3 products have no traces of dairy and are verified as non-dairy.
Maltose (malt sugar) is a disaccharide derived from germinated grains. It is formed when two simple sugars (called glucose) are linked together. It is added as a natural sweetener in VSL#3 products
Yes. VSL#3 products are both Kosher and Halal certified.
No. VSL#3 is GMO free.
VSL#3 can be consumed with all types of drugs. If you take it with antibiotics, it will not harm you, but the effects of VSL#3 products may be reduced since the antibiotics inactivate the microorganisms in VSL#3.
No side effects have been registered in the use of the VSL#3 for children In USA, VSL#3 was determined to be Generally Recognized As Safe (GRAS).
You should always report any unexpected reaction after starting VSL#3 to your physician so that the symptom may be evaluated in the context of your general health history.
Mild bloating may occur during the first few days after starting to use VSL#3. This is usually a transitory phenomenon due to the changing intestinal microflora. If you experience bloating, you may need to reduce your daily intake to allow this adjustment. It is best to report any unexpected reaction after consuming VSL#3 to your physician so that the symptom may be evaluated in the context of your general health history.
Probiotics in general and VSL#3 among them, have an impressive record of patient safety history. In USA, in 2006 an independent panel determined and later in 2017, a panel of qualified experts reconfirmed that VSL#3 is “Generally Recognized As Safe” (GRAS) for the dietary management of certain medical conditions.
Although VSL#3 contains naturally occurring, beneficial microorganisms, it is always recommended that VSL#3 is taken only under medical supervision and, therefore, it is necessary to ask your doctor if and how to take VSL#3 during pregnancy.
For medical support please refer to local website