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 www.VSL3.com.

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 Amazon.com 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.


Sincerely,

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

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

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.

Saturday, January 12, 2008

Is the probiotic VSL#3 gluten free?



Is the probiotic VSL#3 gluten free?

Reports of the probiotic VSL#3 may contain small amounts of gluten are quite disturbing to me because I have recommended it to many of patients. I have also taken it personally and recommended to my wife who has severe celiac disease complicated by the skin disorder dermatitis herpetiformis. So, I initiated an investigation. My research indicates flavored VSL#3, containing maltose derived from barley may not be gluten free, but the unflavored powder and capsule preparations are likely gluten free. I review my research and discuss my the importance of this issue as well as provide my opinions and recommendations regarding the use of VSL#3 below. Interestingly, the U.K. website for VSL#3 states it is not gluten free.



What does the maker of VSL#3 say about its gluten free status?

A medical affairs representative for Sigma Tau Pharmaceuticals, the maker of VSL#3, gave me permission to write about our conversation. I also spoke to Mary Schluckebier, Executive Director of the Celiac Sprue Association (CSA), for over an hour. We spent some time jointly researching on-line. Then I spent another several hours into the wee hours of the night doing my own research. I reviewed numerous scientific articles about VSL#3, malt, maltose, malt dextrin and our nemesis, gluten cross contamination.

What did I learn about the gluten free status of VSL#3?

Here is what I have determined regarding the gluten free status of VSL#3. According to the company, maltose in VSL#3 is derived from barley. Maltose is a disaccharide or two-chain sugar. The company believes that this maltose is gluten free because only the sugar is present after the extensive process of refinement process. However, they concede they have not formally tested the VSL#3 preparations for the presence of gluten. They are planning to have VSL#3 “officially certified” gluten free by formal testing.

Do all VSL#3 preparations contain maltose?

No, not all the VSL#3 preparations contain maltose. If my research is correct, only the flavored powdered packets contain maltose. The unflavored powder packets and capsules do not list maltose as an ingredient. What I can’t answer is if there is any cross contamination occurring of these preparations with the maltose containing flavored VSL#3. There recently has been released a prescription form of VSL#3, VSL#3 DS, that is double strength of the over the counter capsule. I have found that many insurances cover VSL#3 DS, especially when prescribed for accepted indications like traveler's diarrhea, antibiotic associated diarrhea, c. difficile colitis, Crohn's disease and colitis. I am unable to confirm that the double strength capsule is free of maltose but the standard strength does not contain maltose. The maltose is presumably added to the flavored powder form of VSL#3 as a sweetener to increase it acceptance to the consumer.



What do I recommend regarding the use of VSL#3 by those on a gluten free diet?

My common sense recommendation is that, those with celiac disease or NCGS should avoid the flavored VSL#3 preparations. If you are highly sensitive to gluten you may need to avoid the other preparations pending a formal determination of their gluten free status. Overall, I believe the risk gluten exposure from unflavored VSL#3 is extremely low. The flavored preparation containing maltose, though probably safe, in my opinion, is not worth the risk. The company representative is volunteered to update me on any additional information they have or changes that occur in the formulation or gluten free certification process.

Why am I so interested in VSL#3?

Probiotic bacteria break down gluten and increase intestinal tight junctions, decreasing permeability or leaky gut. Gluten increases intestinal permeability. In the past I have recommended VSL#3 probiotic for those with celiac disease and non-celiac gluten sensitivity based on experimental data that suggest it be protective. I continue to recommend it to many of my patients especially those with Crohn’s disease, colitis, irritable bowel syndrome, food allergy and intolerance, and after antibiotics or bowel preparation for colonoscopy. The latter I often use the analogy of a “radiator flush” of the GI tract.

Is maltose gluten free?

Maltose is commonly known as barley sugar though it can be produced by fermentation of other grains in presence of enzymes. Maltose when created in the laboratory from fermentation of malt may contain traces of gluten or gluten breakdown protein fragments. Mary Schluckebier and I agree it is nearly impossible to determine or prove at this time if a source of maltose is free of any gluten related protein fragments.

Are there fragments of gluten that could be a problem?

It also appears that fragments of gluten or gliadin may be capable of getting through the gut wall quite easily. These fragments also appear to be capable of eliciting an immune response in those with celiac disease or who have the genetic predisposition of the presence of HLA DQ2 and/or DQ8 protein patterns on their white blood cells.

What is the status of a gluten free standard in the U.S.?

Though Congress mandated the FDA come up with a formal standard for gluten free. Much debate and lobbying appears to be leading to the FDA to accept as a definition of gluten free as containing less than 20 parts per million of gluten not zero gluten. Many physicians, food scientists, and food industry officials believe that this is a safe level.

Is less than 20 parts per million acceptable as a gluten free standard?

I agree with the CSA and many others that the only acceptable level of gluten is 0 PPM. I base my opinion on extensive professional clinical experience, review of the mountain amount of scientific evidence and my own personal experience living with someone with severe celiac disease and dermatitis herpetiformis. You can find out more about these issues by visiting the CSA website www.csaceliacs.org.

Exciting and controversial new information coming from Dr. Celiac, the Food Doc.

I will be following today's post with a more detailed scientific review of VSL#3 including scientific article references. We will also resume our review of leaky gut with another installment of the series explaining the anatomy and physiology of the gut. I will also posting important information concerning the genetics of gluten sensitivity and celiac disease. Of serious concern to me is recent discovery, confirmed by Enterolab, that they do not test or report the alpha subunits of the DQ pattern. This means it is possible that some who have undergone testing through Enterolab may in fact be carrying at least a minor subunit of these high risk genes DQ2 and/or DQ8 that does predispose to celiac disease rather than just non-celiac gluten sensitivity. There is also exciting new information on the genetics of celiac disease. Stay tuned.


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

References:

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

Tuesday, January 01, 2008

Leaky gut- Part 2 The concept of gut permeability.






Various substances, especially nutrients, water, salt, minerals and vitamins must pass through either through the cells lining gut or between the cells (paracelluar) when the tight junctions are allowed to open.

Small substances such as simple sugars and water pass easily through the cells but larger substances need more space and must come through between the cells in the paracelluar space by triggering zonulin to act on occludens to open up the tight junctions, making the gut lining in essence temporarily “leaky”.

The increase in gut permeability is important for normal absorption and secretion function of the digestive tract. However, abnormal increases in gut permeability are now recognized as being very important if not the critical step in various disease processes.

Though many in the medical field are now researching and publishing articles on gut permeability, including using terms such as leaky gut or leaky intestine, there is still a great deal of resistance to the term “leaky gut” because of its use by the lay public and complementary or alternative practitioners for years.

However, increase gut permeability or leaky gut is now believed to be critical in the risk for and development of Celiac disease and Crohn’s disease. Gluten increases gut permeability in normal individuals but much more so in those with Celiac disease. Many factors can increase gut permeability including stress, various medications especially non-steroidal anti-inflammatory (NSAIDS e.g. Motrin, ibuprofen, Advil, Aleve), infections especially viral gastroenteritis, and altered levels of normal gut microorganisms (yeast and bacteria).

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

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Wishing all of you a Happy New Year,
Sincerely,


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

Leaky Gut Part 1-The intact gut lining





To help those who are reading my blog understand the role of the digestive tract in health and disease I am writing a series of short articles. First we will explore the basic anatomy and function of the gut so you can understand the role of food proteins, bacteria, yeast, medication and stress in leaky gut. The first concept to understand is that of the limited protective barrier provided by the single layer of intestinal cells.

A single layer of cells only lines our digestive tract. These cells are joined together by proteins that produce tight junctions in the intact gut. These tight junctions serve as a barrier as well as a normal site of entry. Surrounding these barrier cells are mobile immune cells that contribute to the primary immune defense of the gut.

The lining cells are types of epithelial cells. They are named by their location and function. In the small intestine or bowel these cells are called enterocytes. In the intestine these epithelial cells or enterocytes are positioned very close to each other, “shoulder to shoulder” if you will. Connecting them are protein “scaffoldings”. The connections produced “tight junctions” (TJ). The proteins forming the tight junctions include proteins called occludens (occlude the tight junctions) that are regulated by another set of proteins, primarily zonulin (the “zone regulator or foreman”).

This single cell lining of the digestive tract is part what is called the innate immune defense system. The cells form a barrier or wall protecting the inside of the human body. The intact gut lining is meant to protect us from potential harmful invaders or toxins such as bacteria, viruses, parasites, toxic yeast, chemical toxins and toxic food proteins. However, in many ways our gut, especially given all the insults we subject it to, is more like the border between the U.S. and Mexico. Our gut may have times where there large areas of potential entry of alien proteins into the body.

Patrolling on the outside of the gut wall are some defensive proteins or antibodies, primarily IgA. Under the surface are various immune fighter cells especially lymphocytes stationed as scouts. They can communicate with other cells to summon reinforcements for a battle. Typically, for example only 1-5 lymphocytes are deployed in a forward location in the tip of a villous in the small intestine.

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


Dr. Scot Michael Lewey
“Dr. Celiac, the food doc”
www.thefooddoc.com
info@thefooddoc.com
1699 Medical Center Point
Colorado Springs CO 80907
Visit the Virtual Practice of Dr. Scot Lewey on HealthTap