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

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.


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

1 comment:

Anne said...

Thanks for all the hard work and the wonderful information. Looking forward to more posts.

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