The New Prescript Assist Reformulation is Dangerous, a Review

 

 

 

 

Prescript Assist old formulation recall notice!

Want to learn all about the HSOs in Prescript Assist? Get a copy of Fix Your Gut.

Everyone in the natural health community used to love Prescript Assist, but many changed their mind because of Safer Medical of Montana’s new formulation. Some self-proclaimed “health gurus” have not changed their recommendations from Sisson,1 to Asprey,2 to Richard Nikoley. Chris Kresser finally changed his recommendation on Prescript Assist.3 Kresser states that they have changed the formulation to a new version that has not been tested for safety and clinically verified, unlike the old Prescript Assist formula. I had doubts about the safety recommendations of the old formula; the new formulation further proved that I was correct in not recommending the supplement.

Many people still believe that Prescript Assist is the best “probiotic” supplement since sliced gluten-free bread.

However, why is that?

In theory, Prescript Assist appears to be a perfect HSO supplement. Most of the “probiotics” in the supplement are heat-stable and shelf-stable. Most of these homeostatic soil organisms are either encapsulated in endospores, pH-resistant to survive stomach acid exposure, or produce biofilm when they colonize. Hopefully, they will survive your stomach acid and eventually colonize the large intestine for your benefit.

Endospores are dormant, tough encapsulations that protect the bacteria from your immune system, antibiotics, antibacterials, and even probiotics. Bacteria can also lie dormant in endospores until their environment becomes favorable for faster reproduction and survival. Bacterial endospores may also become opportunistic in a host, share in a “probiotic” community with other true probiotics for a time, or slowly replicate to form larger colonies. Bacterial endospores can survive without nutrients for a long time and resist UV radiation, desiccation, high temperatures, extreme freezing, and most chemical disinfectants.4

Kresser used to claim that the HSO’s found in Prescript Assist are non-toxic:5

“Finally, Prescript-Assist microflora are recognized Class 1 Etiological Agents, non-toxic, non-pathogenic, from independently maintained lines — this is well documented in both of the Clinical Therapeutics Articles. More than a decade of use as a supplement has revealed no adverse effects and/or side effects [including reportedly patients with impaired immune systems], as well as the initial demonstrations with repeated consumptions of doses amounting to 500X that recommended for ordinary daily use with no ill effect.”

According to Chris Kresser Prescript Assist used to be the safest probiotic ever produced. I guess my doubts are unfounded! It is too bad that Safer Medical of Montana changed their formula from an HSO probiotic that I would not recommend to a firm recommendation that no one should ever consume this “probiotic” supplement.

My Issues with Prescript Assist

It is unknown if most of the microorganisms in Prescript Assist are part of normal human flora. Many of the microorganisms have no human studies or research studies. We might gain more information about the interaction between the microorganisms used in Prescript Assist and their human hosts once the Human Microbiome Project6 is completed, but it is truly unknown if these microorganisms are native flora.

You might be asking yourself. What is the significant controversy?

The main issue with probiotics using unstudied or lesser-studied strains is that supplementing with any microbe with unknown pathogenic capabilities in even healthy people is playing with fire. We do not know what these organisms can do to our health without proper research. Only one study was performed (the second study was just a one-year extension of the previous study) on the old formulation of Prescript Assist.

The original study lasted two weeks and involved only twenty-six participants. It utilized an irritable bowel syndrome (IBS) questionnaire to assess initial symptoms and any improvements throughout the study. The second study was a one-year follow-up survey involving twenty-two participants from the first study. The authors concluded that since twenty-two participants reported feeling better after taking Prescript Assist for one year, it is safe to reduce generalized IBS symptoms in the short term (a couple of weeks) and long term (one year).

However, I have some concerns regarding the authors’ conclusions. First, they relied on surveys, one of the weakest forms of scientific data, and had a tiny sample size. We need more comprehensive studies before making broad conclusions. Whether or not you agree with Chris Kresser’s claim that previous studies prove that Prescript Assist is safe and effective, it’s important to note that the new formulation of Prescript Assist lacks any supporting studies regarding its effectiveness or safety.

We are left wondering: do these inadequately researched strains enhance our digestive or overall health, or could they lead to severe and hard-to-treat opportunistic infections? Without proper research into these organisms and their relationship to our microbiome, we cannot be certain of the outcomes.

HSOs That Are Not Considered Normal Human Flora or Have Non-Existent Human Interaction Research in Prescript Assist7

  • Arthrobacter globiformis
  • Azospirillum brasiliense
  • Azospirillum lipoferum
  • Azotobacter chroococcum
  • Azotobacter paspali
  • Azotobacter vinelandii
  • Bacillus amyloliquefaciens
  • Bacillus atrophaeus
  • Bacillus brevis
  • Bacillus firmus
  • Bacillus marcerans
  • Bacillus megaterium
  • Cellulomonas fimi
  • Kurthia zopfii
  • Nocardioides simplex
  • Rhodobacter sphaeroides
  • Rhodopseudomonas palustris
  • Rhodospirillum rubrum
  • Streptomyces griseus
  • Streptomyces griseoflavus
  • Streptomyces venezuelae

Documented Opportunistic HSOs in Prescript Assist

Opportunistic Microorganisms That Were Removed From the Previous Formulation:

  • Acinetobacter calcoaceticus8 9 10 11
  • Phanerochaete chrysosporium12

Opportunistic Microorganisms in the New Formulation:

All of these listed HSOs are known to cause opportunistic infections in humans or can cause severe health issues, some worse than others.

Opportunistic infections and dysbiosis are rare with Micrococcus luteus and Pseudomonas putida. Micrococcus luteus is a typical inhabitant of our microbiome and is found in the mouth, mucosa, respiratory tract, skin, and pharynx. Micrococcus luteus dysbiosis is rare but can occur in people with compromised immune systems. Pseudomonas putida dysbiosis is rarely reported in the literature compared to its cousin, which is in Prescript Assist, Pseudomonas fluorescens.

Pseudomonas fluorescens has even been implicated as the cause of Crohn’s disease (I believe it is a coinfection instead of the direct cause.)

These bacteria can produce hardy endospores and/or biofilm, which makes it harder to reduce their colonies if they become opportunistic. Reducing opportunistic Lactobacillus acidophilus colonies is much easier than these spore-forming bacteria.

A grave error made in the reformulation of Prescript Assist is the addition of the bacteria Bacillus thuringiensis to Prescript Assist. Bacillus thuringiensis produces the pesticide BT (Bacillus thuringiensis) toxin (delta-endotoxin), and its genes are inserted into genetically modified corn to produce the toxin. The bacteria Bacillus thuringiensis are applied to some organic crops as a pesticide to produce the BT toxin to kill caterpillars. However, the bacteria and the toxin can be thoroughly washed off during food preparation. I am not here to debate whether or not genetically modified corn (which I believe it is, especially in people with a higher stomach pH) harms our digestive system because researchers claim BT toxin is inactivated by stomach acid. Stomach acid inactivating the toxins is why the researchers claim it does not harm the mammalian microbiome compared to the alkaline microbiome of insects. I, however, will declare that ingestion of Bacillus thuringiensis over time would possibly germinate the bacteria leading to dysbiosis, leaky gut, cellular intestinal damage, autoimmunity, and gut inflammation from the production of BT toxin that would be active in a more alkaline environment (for example our small intestine which has an alkaline pH of around 7-8.5 pH which is enough to activate the toxin) within our gut. Finally, contaminated Bacillus thuringiensis containing products can contain beta-exotoxins, which are toxic to humans. Beta-exotoxins are not supposed to be in any product that includes Bacillus thuringiensis or anything produced by Bacillus thuringiensis. Still, it is unknown if Safer Medical of Montana tests for it in the new Prescript Assist formulation.22 23 24

Is the”Probiotic” Supplement Just Capsuled and Bottled Fertilizer?

When you compare the labels, Prescript Assist appears to be a soil inoculant produced by Tainio Biologicals. Both products contain many of the same bacteria.

Tainio Biologicals also has an interesting disclaimer about the soil inoculant:

Disclaimer: All products are for Agricultural use only. By your purchase of this product(s) you agree to only use the product(s) in strict compliance with the instructions of use on the product label and recognize that Tainio Biologicals, Inc. is not liable in any manner for any off label use.

I do not believe Safer Medical of Montana should use Tainio Biologicals soil inoculant for its “probiotic” supplement. It should only be used for agricultural purposes, not for human consumption.

Finally, Safer Medical of Montana has threatened researchers with legal action for reporting concerns about Prescript Assist. George Ackerson, the founder and owner of Safer Medical of Montana, allegedly has a shady past. Read Greg Caton’s blog Meditopia for more information.

Now, I hope you understand why I cannot recommend that any of my clients supplement with Prescript Assist. I also hope you look over my research and investigate Prescript Assist on your own.

 

  1. http://www.marksdailyapple.com/definitive-guide-to-primal-supplementation/#axzz31t4SchA6
  2. http://www.bulletproofexec.com/the-red-meat-scapegoat-the-new-york-times-carnitine-heart-disease-and-science/
  3. https://store.chriskresser.com/pages/prescript-assist-announcement
  4. https://micro.cornell.edu/research/epulopiscium/bacterial-endospores
  5. https://chriskresserlac-shopify.helpjuice.com/questions/47699-Prescript-Assist-and-*spore-forming-organisms*
  6. http://commonfund.nih.gov/hmp/index
  7. https://safermedicalmt.com/
  8. http://www.ncbi.nlm.nih.gov/pubmed/846390
  9. http://www.ncbi.nlm.nih.gov/pubmed/362918
  10. http://link.springer.com/article/10.1007%2FBF01643394#page-1
  11. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC172888/
  12. http://onlinelibrary.wiley.com/doi/10.1002/rcr2.31/abstract
  13. https://goo.gl/sO6jRc
  14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1364539/
  15. https://academic.oup.com/femspd/article/48/3/410/506801
  16. https://www.ncbi.nlm.nih.gov/pubmed/629642
  17. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3141704/
  18. https://journals.lww.com/pidj/Fulltext/1996/08000/MICROCOCCUS_LUTEUS_AS_A_CAUSE_OF_RECURRENT.19.aspx
  19. http://www.gutpathogens.com/content/2/1/16
  20. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC133002/
  21. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3434797/
  22. http://www.jbc.org/content/279/53/55168.full
  23. http://www.tandfonline.com/doi/pdf/10.1080/09540105.2017.1313200
  24. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5236067/