Reformulating the new Prescript Assist is dangerous, a review
Note on the recall of old formulations from Prescript Assist!
Want to learn all about the HSOs in Prescript Assist? Get a copy of Fix Your Gut.
Everyone in the naturopathic community used to love Prescript Assist, but many changed their minds because of Safer Medical of Montana's new formulation. Some self-proclaimed “health gurus” have not changed their recommendations, from Sisson to Asprey to Richard Nikoley. Chris Kresser finally changed his recommendation for Prescript Assist. Kresser states that they changed the formulation to a new version that, unlike the old Prescript Assist formula, has not been safety tested and clinically verified. I had doubts about the safety recommendations of the old formula; The new formulation also proved that I was right not to recommend the supplement.
Many people still believe that Prescript Assist is the best “probiotic” supplement since sliced gluten-free bread.
But why is that?
In theory, Prescript Assist seems to be a perfect HSO complement. Most “probiotics” in dietary supplements are heat-resistant and shelf-stable. Most of these homeostatic soil organisms are either encapsulated in endospores, pH stable to survive exposure to stomach acid, or produce a biofilm upon colonization. Hopefully they survive your stomach acid and eventually colonize the colon to your benefit.
Endospores are dormant, sturdy capsules that protect the bacteria from your immune system, antibiotics, antibacterials, and even probiotics. Bacteria can also lie dormant in endospores until their environment is favorable for faster reproduction and survival. Bacterial endospores can also become opportunistic in a host, forming a “probiotic” community with other true probiotics for a time, or multiplying slowly to form larger colonies. Bacterial endospores can survive for long periods without nutrients and can withstand UV radiation, desiccation, high temperatures, extreme freezing, and most chemical disinfectants.
Kresser always claimed that the HSOs contained in Prescript Assist were non-toxic:
“Finally, Prescript-Assist microflora are recognized Class 1 aetiological agents, non-toxic, non-pathogenic, from independently maintained lines – this is well documented in both Clinical Therapeutics articles. More than a decade of use as a dietary supplement has revealed no adverse effects and/or side effects.” [including reportedly patients with impaired immune systems]and the first demonstrations with repeated doses of 500 times the recommended dose for normal daily use without adverse effects.”
According to Chris Kresser, Prescript Assist was the safest probiotic ever created. I guess my doubts are unfounded! It's a shame 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 problems with Prescript Assist
It is not known whether most of the microorganisms in Prescript Assist are part of normal human flora. There are no human studies or research studies for many of the microorganisms. Once the Human Microbiome Project is complete, we may receive more information about the interaction between the microorganisms used in Prescript Assist and their human hosts. However, it is not really known whether these microorganisms are native plants.
You may be wondering. What is the essential controversy?
The main problem with probiotics that use unstudied or less studied strains is that supplementing with microbes with unknown pathogenic abilities is playing with fire, even in healthy people. Without proper research, we don't know what these organisms can do for our health. Only one study was conducted using the old formulation of Prescript Assist (the second study was just a one-year extension of the previous study).
The original study lasted two weeks and included only 26 participants. An irritable bowel syndrome (IBS) questionnaire was used to assess initial symptoms and any improvement during the study. The second study was a one-year follow-up survey with 22 participants from the first study. The authors concluded that it is safe to reduce generalized IBS symptoms in the short term (a few weeks) and long term (a year), as 22 participants reported feeling better after taking Prescript Assist for a year.
However, I have some concerns about 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 we can draw general conclusions. Regardless of whether you agree with Chris Kresser's claim that previous studies show that Prescript Assist is safe and effective, it is important to note that the new formulation of Prescript Assist has no supporting studies on its effectiveness or safety.
We wonder: Do these under-researched strains improve our digestion or overall health, or could they lead to serious and difficult-to-treat opportunistic infections? Without proper research into these organisms and their relationship to our microbiome, we cannot be sure of the results.
HSOs that are not considered normal human flora or have no research on human interaction in Prescript Assist
- Arthrobacter globiformis
- Azospirillum brasiliense
- Azospirillum lipoferum
- Azotobacter chroococcum
- Azotobacter paspali
- Azotobacter vinelandii
- Bacillus amyloliquefaciens
- Bacillus atrophaeus
- Bacillus short
- Bacillus is solid
- Bacillus marcerans
- Bacillus megaterium
- Cellulomonas fimi
- The Zopfii trap
- Nocardioides simplex
- Rhodobacter sphaeroides
- Rhodopseudomonas palustris
- Rhodospirillum red
- Streptomyces griseus
- Streptomyces griseoflavus
- Streptomyces venezuelae
Documented opportunistic HSOs in Prescript Assist
Opportunistic microorganisms removed from previous formulation:
- Acinetobacter calcoaceticus
- Phanerochaete chrysosporium
Opportunistic microorganisms in the new formulation:
All of these HSOs listed are known to cause opportunistic infections in humans or can cause serious health problems, some worse than others.
Opportunistic infections and dysbiosis are rare in Micrococcus luteus and Pseudomonas putida. Micrococcus luteus is a typical resident of our microbiome and occurs in the mouth, mucous membranes, respiratory tract, skin and throat. Micrococcus luteus Dysbiosis is rare but can occur in people with weakened immune systems. Pseudomonas putida dysbiosis is rarely described in the literature compared to its cousin Pseudomonas fluorescens, which is present in Prescript Assist.
Pseudomonas fluorescens has even been implicated as a cause of Crohn's disease (I believe it is a co-infection and not the direct cause).
These bacteria can produce robust endospores and/or biofilm, making it more difficult to reduce their colonies when they become opportunistic. Reducing opportunistic Lactobacillus acidophilus colonies is much easier than with these spore-forming bacteria.
A major flaw in the reformulation of Prescript Assist is the addition of the bacterium 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 bacterium Bacillus thuringiensis is used as a pesticide on some organic crops to produce the BT toxin, which kills caterpillars. However, the bacteria and toxin can be thoroughly washed off during food preparation. I'm not here to debate whether genetically modified corn (which I believe is the case, especially in people with higher stomach pH) is harmful to our digestive system, because researchers claim that the BT toxin is inactivated by stomach acid. The researchers claim that the stomach acid that inactivates the toxins does not harm the mammalian microbiome compared to the alkaline microbiome of insects. However, I would like to explain that over time, ingesting Bacillus thuringiensis would potentially cause the bacteria to germinate, leading to dysbiosis, leaky gut, gut cellular damage, autoimmunity, and intestinal inflammation through the production of BT toxin, which would be active in our gut in a more alkaline environment (e.g. our small intestine, which has an alkaline pH of around 7-8.5, enough to activate the toxin). Finally, contaminated products containing Bacillus thuringiensis may contain beta-exotoxins, which are toxic to humans. Beta exotoxins must not be contained in any product that contains Bacillus thuringiensis or anything produced by Bacillus thuringiensis. However, it is unknown if Safer Medical of Montana is testing for this in the new Prescript Assist formulation.
Is the “probiotic” supplement just capsuled and bottled fertilizer?
Comparing the labels, Prescript Assist appears to be a soil inoculant manufactured by Tainio Biologicals. Both products contain many of the same bacteria.
Tainio Biologicals also has an interesting disclaimer about the soil vaccine:
Disclaimer: All products are intended for agricultural use only. By purchasing this product(s), you agree to use the product(s) only in strict accordance with the directions for use on the product label and acknowledge that Tainio Biologicals, Inc. is in no way liable for any unlabeled use.
I do not believe that Safer Medical of Montana should use Tainio Biologicals soil vaccine for its “probiotic” supplement. It should only be used for agricultural purposes, not for human consumption.
Finally, Montana-based Safer Medical threatened researchers with legal action for reporting concerns about Prescript Assist. George Ackerson, the founder and owner of Safer Medical of Montana, reportedly has a shady past. For more information, see Greg Caton's blog Meditopia.
Now I hope you understand why I cannot recommend any of my clients to use Prescript Assist. I also hope you'll check out my research and investigate Prescript Assist on your own.
