Sunday, January 27, 2008

VSL#3 DS probiotic gluten free but only available in powder by prescription yet effective in colitis and may be beneficial in Celiac disease

In a previous report on the probiotic VSL#3, I stated that VSL#3 DS (double strength) came in a capsule form that is gluten free. VSL#3 DS does not come in capsules. However, it does appear to be gluten free. VSL#3 DS is only available in sachets of powder. VSL#3 DS requires a prescription but the other forms of VSL#3 are available over the counter (OTC) without the need of a doctor's prescription.

As far as I can determine, the prescription strength form of VSL#3, VSL#3 DS, is gluten free since it is unflavored. The flavored form of VSL#3 powder contains maltose that according to the manufacturer, is derived from barley. Though they report the maltose is highly processed to the point they believe no gluten residues remain they cannot insure it is gluten-free.

To take VSL#3 DS and VSL#3 OTC powder, you simply dissolve one or more packets in water or another liquid and drink it. The OTC VSL#3 capsules can be taken orally and do not contain maltose so should be free of gluten like the unflavored OTC powder and the prescription form of the powder. The dosing of VSL#3 recommended varies according the the strength, form and indication.

Each sachet of VSL#3 DS powder contains 900 billion bacteria. The OTC form of VSL#3 powder contains 450 billion live bacteria. Eight different species including four stains of lactobacilli, three strains of bifidobacter and Streptococcus salivarius, subspecies thermophilus are present in highly concentrated live freeze dried preparation. The estimate of total bacteria in the digestive tract is 100 trillion.

The base dose of VSL#3 DS is ½ to 1 packet orally daily but doses as high as 2-4 packets orally daily are recommended to treat active ulcerative colitis. The over the counter forms contain lower numbers of active probiotic bacteria.

Since the over the counter flavored sachet packets of VSL#3 contain maltose derived from barley as a sweetener they can be assumed gluten-free. A representative from the medical affairs division of the manufacturer, Sigma Tau Pharmaceuticals, confirmed this with me by phone recently. She did say the company was seeking to have the preparations certified as gluten free. However, it is important to remember that the FDA has not yet decided on a gluten-free standard. There is a concern that up to 20 parts per million will be accepted as “gluten-free”. It is not yet known if Sigma Tau Pharmaceuticals will be able to guarantee any of the preparations are completely free of gluten.

The unflavored packets and capsules are free of the sweetener maltose, as is the DS powder but all of the preparations may contain traces of dairy. There is extensive scientific data on VSL#3 in the literature. Based on some of that data, I am prescribing VSL#3 DS powder and recommending over the counter VSL#3 capsules and unflavored powder to my patients regularly. I am advising my patients to avoid the flavored form of VSL#3. Some of my patients report nausea with VSL#3, especially the double strength powder. Reducing the dose often helps prevent this side effect. I also caution those who are dairy allergic or sensitive to avoid VSL#3.

Since VSL#3 DS is only available by prescription and it is approved for the treatment of colitis, many insurance companies will cover it. Some also cover the over the counter preparations when prescribed in writing by a physician. The over the counter forms that do not require a prescription. VSL#3 can be difficult to find. In our area more pharmacies are carrying it but typically you have to ask the pharmacy staff for it. Since it is recommended that the preparations be refrigerated many pharmacies keep VSL#3 in with other prescription medications in a refrigerator behind the counter. Over the counter forms of VSL#3 can also be purchased on-line directly from Sigma Tau Pharmaceuticals at

Other probiotic preparations that I understand are gluten free are Flora Q and Ultimate Flora. Both are also reportedly dairy-free. Like VSL#3 they contain multiple strains of live active probiotic bacteria and are available over the counter The brand of probiotic yeast I recommend is Florastor. It contains Saccharomyces boulardii lyo, an active form of the yeast naturally present in the fruit mangosteen. It has been reported to improve leaky gut, treat and prevent relapses of Crohn’s disease and treat antibiotic associated diarrhea due to Clostridium difficile infection. However, it should be used with caution under a doctor’s supervision if you are immune suppressed. I avoid recommending it for my patients who are taking immune suppressing medications. There are rare reports of blood stream infection in immune suppressed individuals otherwise it appears to be very safe. The most common brand of Saccharomyces boulardii, Florastor, does contain lactose. Other forms of this probiotic yeast are available but should be checked for gluten.

VSL#3 does not yet have an approved indication for Celiac disease like it does for ulcerative colitis or pouchitis. Scientific data continues to accumulate supporting its use for the treatment and prevention of relapse in Crohn’s disease, treatment of antibiotic associated diarrhea and Clostridium difficile infection, and treatment of traveler’s diarrhea. There are published reports that VSL#3 bacteria are capable of breaking down toxic gliadin.

There are several scientific studies indicating that altered gut bacteria play an important role in the development of Celiac disease and failure to respond to a gluten free diet. Probiotic bacteria in sourdough bread has also shown promise in reducing the toxicity of gluten. Therefore,probiotic bacteria may be protective in Celiac disease. It has been shown that probiotic bacteria increase tight junctions or reduce leaky gut, suppress bad bacteria, compete with bad bacteria for nutrients and binding sites of the intestinal wall of the gut, reduce secretions and inflammatory reaction from infection, and have the ability to enhance the body's production of defensive proteins and intestinal digestive enzymes.

On the basis of the known and theoretical advantages of probiotics I recommend probiotics to all my patients, especially those with Celiac disease, colitis, Crohn's disease or IBS. One my suggestions includes taking a probiotic before meals eaten out in restaurants is based on the theory that probiotic bacteria have the ability break down gluten into a non-toxic form as well as the known protective effects of probiotics described above. If you inadvertently ingest gluten due to cross contamination you may, at least theoretically, be somewhat protected.

Until medications such as combined enzyme therapy that breaks down gluten into a non-toxic form or a tight junction promoter such as AT 1001 are available there is nothing to offer the patient with Celiac disease except the admonition to be careful and follow a strict gluten-free diet. Those of us following such a diet and living in the "real world" know this is much easier than said. At least we know that probiotic bacteria may help promote tighter junctions in the gut reducing risk of gluten or gliadin that is eaten by accident from getting through to initiate an immune response. Again, this is speculative on my part but overall I believe the potential benefit probably outweighs the risk. However, I do recommend avoiding the flavored form of VSL#3 do to the possibility the maltose may contain gluten protein particles.

In the past I have told patients that taking probiotic bacteria while taking an antibiotic didn't make sense since the bacteria would be killed by the antibiotic. Instead, I recommended that they start after they completed their antibiotic. However, a recent study indicates that taking a probiotic while on antibiotics may decrease the risk of antibiotic associated diarrhea and C. difficile infection. C. difficile infection is an increasingly serious problem in people treated with antibiotics, especially in hospitalized patients receiving very powerful or broad-spectrum antibiotics. It can be severe and life threatening, especially for elderly patients.

In future posts I will review the benefits of probiotic bacteria and yeast. I am also working on an e-book that comprehensively reviews probiotics. These supplements may critical in the prevention and treatment of leaky gut. Increased gut permeability or leaky gut is increasingly being recognized as the critical predisposing factor to the development of Celiac disease, colitis, Crohn’s disease and several non-digestive autoimmune disorders.

A excellent introduction to probiotics is the approximately 100 page paperback "The Consumer's Guide to Probiotics". You can purchase it directly from by clicking on the link below. Journey with me as we continue our discovery of new information leading to a “healthy gut, healthy life" by joining the Food Doc Community today. It is simple and free. You are only signing up for free e-mail updates. The only e-mails you will receive will be from me and they will consist of free helpful information that you can use. Your e-mail will never be disclosed to any third parties and you are free to unsubscribe to the Food Doc e-mail list at any time. We hope to have a new quarterly full color e-newsletter packed with helpful information and insights out within a month so please stay tuned.


Dr. Scot Michael Lewey
“Dr. Celiac, the food doc”
1699 Medical Center Point
Colorado Springs CO 80907

Copyright © 2008, The Food Doc, LLC, All Rights Reserved.

Selected References:

Bibiloni R. et al. "VSL#3 Probiotic-Mixture Induces Remission in Patients with Active Ulcerative Colitis" American Journal of Gastroenterology 2005; 100:1539-1546

Chapman TM, et al. "Spotlight on VSL#3 probiotic mixture in chronic inflammatory bowel diseases" Biodrug. 2007; 21(1):61-3.

De Angelis M. et al. "Probiotic preparation has capacity to hydrolyze proteins responsible for wheat allergy" J Food Prot. 2007 Jan; 70(1):135-44.

De Angelis M. et al. "VSL#3 probiotic preparation has the capacity to hydrolyze gliadin polypeptides responsible for Celiac Sprue" Biochim Biophys Acta. 2006 Jan; 1762(1):80-93.


Anonymous said...

In the 6th paragraph you state the following:
Since the over the counter flavored sachet packets of VSL#3 contain maltose derived from barley as a sweetener they can be assumed gluten-free.

Shouldn't that read "they cannot be assumed gluten-free."?

I wonder what your thoughts are on using VSL#3 or some other similar probiotic for treatment of Microscopic Colitis? Also what about for treatment of Small Intestinal Bacterial Overgrowth?


Martin Johns said...

Why does the bacteria count make this product a prescription-only product? What are the dangers? How about all the over-the-counter probiotics on the market? For example, there are many that have been reviewed at NutritionalTree. Some are quite inexpensive but have good reviews.

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