# VSL#3 Probiotic Now Generally Recognized as Safe (Gras) for IBS



## Jeffrey Roberts

Source: Chamberlain Communications Group Released: Fri 18-Aug-2006, 09:50 ET VSL#3 Probiotic Now Generally Recognized as Safe (Gras) for the Dietary Management of Irritable Bowel SyndromeDescriptionNew data has shown that VSL#3 provides effective relief in the dietary management of serious intestinal disorders such as ulcerative colitis and pouchitis. Based on recently published research from the Mayo Clinic, an independent panel of qualified experts has determined that VSL#3 is generally recognized as safe (GRAS), under the conditions of intended use as a medical food for the dietary management of irritable bowel syndrome (IBS). Newswise â€” New data has shown that VSL#3 provides effective relief in the dietary management of serious intestinal disorders such as ulcerative colitis and pouchitis. Based on recently published research from the Mayo Clinic, an independent panel of qualified experts has determined that VSL#3 is generally recognized as safe (GRAS), under the conditions of intended use as a medical food for the dietary management of irritable bowel syndrome (IBS). VSL#3 probiotic is a preparation of living microbial cells used extensively for the management of gastrointestinal disorders. Probiotics, because of their potential to help manage GI distress symptoms, are the subject of widespread research. When ingested, probiotics positively influence the composition of the bacterial population in the intestines. Normally, intestinal bacteria act as a protective barrier in the gastrointestinal (GI) tract, but in some situations, the â€˜badâ€™ bacteria outnumber the â€˜goodâ€™ bacteria. IBS is characterized by abdominal pain or discomfort due to gas (flatulence) and bloating that is associated with a change in bowel pattern (loose or more frequent bowel movements, diarrhea and/or constipation, etc). â€œThere is evidence that probiotics such as VSL#3 have a role in the management of inflammatory intestinal disorders such as pouchitis, and increasing evidence that they may alleviate some of the symptoms associated with IBS,â€ said Jay W. Marks, M.D. a board certified internist and gastroenterologist from UCLA/Cedars-Sinai Medical Center. â€œRecent studies have demonstrated that probiotics, including VSL#3, are safe and have a promising therapeutic benefit for IBS patients.â€VSL#3 works by colonizing the GI tract with probiotic bacteria that adhere to the walls and form a barrier that protects the inner layer of the gut from â€œbadâ€ bacteria and other substances that cause inflammation. Results of previous research suggest immune function, motility and the intestinal environment are positively influenced by probiotics. One study looked at the effect of individual bacteria on IBS symptoms, and found probiotics contributed to the production of anti-inflammatory agents, thus reducing inflammation. In addition, probiotic bacteria may also provide relief for patients with functional diarrhea, or IBS with diarrhea, by altering the intestinal environment. Bloated IBS patients (with and without diarrhea) reported experiencing significantly improved bowel control with VSL#3 relative to placebo. Research suggests certain bacteria may influence the secretion of fluids in the colon that contribute to functional diarrhea or IBS with diarrhea. Among all studies, no serious side effects were reported. According to Dr. Marks, â€œPatients and their physicians should be aware of the potential of probiotics such as VSL#3 to manage pouchitis and some symptoms of IBS.â€ GRAS is an FDA designation that acknowledges certain food additives as safe under the conditions of their intended use by qualified experts. To receive such recognition, the product must establish a consensus of expert opinion regarding the safety of its use based on a review of scientific evidence. About Sigma-Tau Pharmaceuticals, Inc.Working to Make Rare Diseases Even RarerThere are some 6,000 identified rare diseases that affect approximately 10 million patients in the United States. The founding principle and core belief of Sigma-Tau Pharmaceuticals, Inc., a wholly owned U.S. subsidiary of Sigma-Tau S.p.A., is that finding therapies for rare diseases is just as important as finding ones for more common diseases. After all, to the patient, thereâ€™s nothing â€œrareâ€ about their condition. To that end, Sigma-Tau Pharmaceuticals has been focused on rare diseases since its founding, and was one of the first companies to obtain an Orphan Drug Designation in the United State more than 20 years ago. The Sigma-Tau group is always looking to explore entirely new approaches to treating disease. This is illustrated by the companyâ€™s study of the biologic underlying diseases, an alternative approach referred to as â€œbiologic pharmacology.â€ The research is based on the assumption that disease begins at the metabolic level, when the biochemical pathways within cells and communication among them are altered.


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## SpAsMaN*

This product is about ten times more expensive than a regular probiotic.I just wanted to let you know.


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## Jeffrey Roberts

Spasman - Difficult to compare what exactly is a regular probiotic; however, I think that is a huge exaggeration in the cost.It might be better to compare the cost of VSL#3 to prescription medication.Jeff


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## Kathleen M.

You also have to look at bacteria per dollar.VSL#3 has 450 billion bacteria per dose. From Consumer labs most "normal" probiotics give you from 1-35 billion per daily dose.So at $75 for VSL#3 and lets say $10 for a normal probitoic for a month each at a generous 15 billion (most are 1 billion or 3 billion only a few get to double digits). You would need to take a whole months dose of the "normal" ones every single day to get the same number of bacteria running you $300. Much more if it is one of the 1 billion a day.Sometimes things are more expensive for a reason. Having such a large dose of bacteria is part of why it is more expensive than what you can buy cheap.K.


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## Gutguy22

But has there ever been head to head trials of these probiotics? Do they even know if 450 billion is more effective than 35 billion? Might seem like it obviously would be, but I don't think it is so simple, as I don't believe they really understand what is going on with probiotics. I recall lots of talk about how so many probiotics didn't contain as many live bacteria as they claimed, then there was a study showing a probiotic (align?) didn't even need to be alive to show effects. There seems to have been more studies using VSL, I don't know why.


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## Kathleen M.

I think alot of which probiotic gets studies has to do with the company behind it.A lot of supplement companies I do not think feel getting good science about there product out there is needed to make the money they want to make off it.Most people buy supplements based on promises and smoke and do not seem to care about the science (heck in some sectors of the supplement buying public science is evil and not to be trusted). Now if you want to impress the doctors, do science, for sales, that is not needed.I would love to see a very large randomized study comparing several different probitoics. Hopefully there is getting to be enough data that maybe the NIH would fund something like that.K.


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## 14438

Does anyone know what the difference is between Bifantis 35624 (Align) & VSL#3? Is it the same bacteria? Was Align also recognized as safe for IBS? I'm into my 3rd week w/Align, which was easy to find to purchase, but after searching VSL#3, I can't find a site that sells it.


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## Kathleen M.

Um I type VSL #3 into google and the companies site is the first one that pops up http://www.vsl3.com/VSL3/default.aspAlign is one strain of bacteria VSL#3 has many different strains see http://www.vsl3.com/VSL3/about-vsl-works.aspThe FDA doesn't approve of any dietary supplements as safe or effective. They can't regulate them like that. Align was used in some clinical trials in IBSers and did well.K.


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## Kathleen M.

Here is the Align study in IBSers http://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_docsumAnd compared to Lactobacillushttp://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_docsumHere is the VSL#3 study in IBSershttp://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_docsum


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## Misty B

How does VSL#3 compare with Flora Source (by Nutri-Health) for effectively treating IBS? I just happened upon this subject, as I haven't read the boards for some time. I've been sending for the Flora Source for over a year now. Mine comes in capsule form rather than a powder (I prefer capsule).Thanks for any info you can give me!


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## Kathleen M.

It is rare to find any head to head studies. I can find studies for VSL#3 in IBSers but was not able to find much in the way of clinical trials with Flora Source, so I don't think there is any data we can use to compare.Some people find one brand works better for them than another, and I don't think we can predict in any meanfully way who will react well with which product.If a given brand works for you, I'd stick with it.K.


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## 21881

I'm in my last week of a 28-day course of Align. I ordered another 28-day supply. I will finish the two 28-days and switch to VSL 3. I will see if there's a difference. So far the Align is not doing anything for me but the documentation states you should do two 28-days to see total results. Ok...I'm in my 2nd week of Asacol and still have bouts of very loose stools caused by my LC.


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## Jeffrey Roberts

phoenixitc,I switched from Align to VSL#3 in September and found the results in stopping loose stools as remarkable as I found Align. If anything I have probably found VSL#3 more potent than Align so perhaps you will have better results.Jeff


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## 21881

Thanks. I will update after I complete my two months on Align, then again after VSL.


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## 16127

The VSL#3 web site states that it is intended for use under the supervision of a physician. Others (such as Align) don't have that stipulation. What do you supposed is up with that? Are they just covering themselves for liability, etc? Or is there something so different about VSL#3 that you should be under a doctor's supervision while taking it?


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