You’ve likely heard the headlines about the success of “fecal microbiota transplant,” or FMT, i.e., the transfer of fecal material from a presumptively normal “donor,” i.e., negative testing for hepatitis B and C, HIV, no history of illicit drug use, no chronic health conditions such as type 2 diabetes, no recent antibiotic use, no history of cancer or autoimmune diseases, non-obese, stool testing negative for pathogenic microbes such as H. pylori, methicillin-resistant Staphylococcus aureus, among others—as you can imagine, the screening process eliminates >90% of people as donors. Donors also provide material regularly and must undergo repeat testing every several months to ensure continued safety. Donor material is then administered to recipients via nasogastric/duodenal tube, colonoscope, or enema.

Despite such comprehensive efforts to screen donors, there have been a handful of reports of serious adverse effects, especially sepsis, in which antibiotic-resistant organisms entered the bloodstream resulting in critical illness and death. Antibiotic resistance has therefore recently been added to the list of screening items to identify safe donors.

Excitement over the possibilities of fecal transplant were ignited as evidence that the success rate in eradicating Clostridium difficile, C. diff, was around 92% despite the sharply declining rates of success of antibiotics for this dangerous and feared complication of antibiotics (as well as the increasing numbers of people developing “spontaneous” C. diff without preceding antibiotics). Preliminary experiences in FMT for other conditions such as inflammatory bowel diseases, ulcerative colitis and Crohn’s, and irritable bowel syndrome have also yielded positive results, though not as dramatic as that for C. diff. Preliminary evidence also suggests that donors screened for specific features of their stool microbiome composition, e.g., increased Akkermansia and Ruminococcus species, may increase efficacy. Future screening of donors, especially those populating the growing number of stool banks, will likely involved detailed microbial analysis to identify donors with favorable bacterial populations associated with increased efficacy.

There is also growing experience of taking fecal material from donors screened through the above process, but then removing fiber and other particulate matter via repeated filtration, leaving largely bacteria (and viruses), then freeze-dried and encapsulated. The concentrated fecal microbes are then administered via orally-consumed capsules. Preliminary experienced in C. diff. suggests efficacy equivalent to that of conventional methods of administration. A Chinese experience in participants with small intestinal bacterial overgrowth, SIBO, showed efficacy vs. placebo in reducing symptoms of SIBO and H2-breath negativity.

I detail all this due to a provocative and interesting new product (that I have no relationship with) called Equilibrium, a collection of 115 species and strains, 85 of which the company claims are unique and not present in other commercial probiotics. It contains (a meager) one billion CFUs per capsule, meaning no more than 107 (10 million) CFUs of each species/strain, a modest number. (Compare this to, say, our Lactobacillus reuteri yogurt fermented for 36 hours that yields more than 1011 CFUs per serving, or 10,000-times greater counts.) Nonetheless, the company claims that its founder, one of the scientists involved in the NIH-sponsored Human Microbiome Project, identified the species/strains largely lacking from the microbiomes of most modern people, then added this to the mix in this product. Interesting, but their marketing material leaves a lot to be desired in transparency and detail, including:

  • What are the species/strains contained? Strains can be especially important when it comes to keystone species such as L. reuteri, L. gasseri, L. rhamnosus, and B. infantis.
  • They make claims of “interdependence” and “synergy,” meaning that this collection of microbes constitute one or more “guilds” or “consortia” that collaborate in generating various metabolites or suppressing pathogens. But no details on this bold claim are provided.
  • What can we expect from such a low microbial count? Evolving evidence is suggesting that there is indeed a “dose-response” effect, i.e., higher CFU counts yield greater biological effects. It is my suspicion that meaningful effects get underway at 10 billion CFUs per day or greater, >25 billion per day even better.
  • No meaningful human clinical testing exploring the effects of this probiotic mix. (Yes, there is a casual description of a “clinical trial,” on the website that simply showed the product was well-tolerated, improved stool character, and trended towards reduced stress and increased happiness, but no clinically-significant endpoints were reported, e.g., reduced serum LPS, reduced stool calprotectin, normalization of breath-H2 gas, etc.)

Granted, the FTC as well as FDA are watching and it is extremely hazardous to make health claims for a nutritional supplement and perhaps their apparent lack of transparency and details simply reflects regulatory caution.

Of course, some of the Members of my DrDavisInfiniteHealth.com Inner Circle want to know whether we can amplify numbers via yogurt fermentation. What we cannot predict is how this mixture of microbes will behave in dairy or other fermentation since we don’t know what microbes are contained, and what will happen with successive batches of fermentation as the microbes compete and can cause shifts in relative numbers. So this is a big unknown.

This could be a microbiome game-changer, it might not. Despite all we do not know about this product, it is still interesting. Should any of you give this a try, please come back and report your experience with symptoms, bowel habits, AIRE H2-testing, or any other observations you make.

 

 

 

 

 



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