Microbiota Therapeutics – Additional (non-C. difficile) Treatment Areas

The gut microbes play important roles in the body physiology:

  • participate in energy metabolism and likely have a role in conditions such as type 2 diabetes, obesity, and eating disorders
  • help to calibrate immune responses and may help with problems such as autoimmunity, allergies, asthma, and eczema
  • may help with immune responses against cancers
  • play important roles in inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease
  • involved in the function of the nervous system
  • may be involved in neurodevelopmental disorders such as autism
  • may be involved in degenerative diseases associated with aging, such as Alzheimer’s and Parkinson’s disease

Many patients are interested whether intestinal microbiota transplants or any intestinal microbiota therapeutics can help them with any of these conditions. It is important to understand that this frontier in medicine is still in its infancy and we are only starting to explore these questions.

The following are some of the current realities:

C. difficile infection that does not respond to standard therapies (antibiotics) is the only indication for which the FDA currently allows clinical use of IMT outside of clinical trials. The only other mechanism for which the FDA may make an allowance is compassionate treatment of a single patient or a small group of patients. However, the FDA allowance must satisfy two essential criteria. The condition must be life threatening and all standard therapies have been exhausted.

Definitely NOT! First, we need to consider the dosing regimen. The indigenous gut microbes of patients with C. difficile infections that failed all antibiotic treatments have been decimated by all those antibiotics. A single dose of donor microbes restores normal microbial composition of stool of patients because there are few competitor microbes. However, the dosing regimen for other conditions generally needs to be much more intense in order to achieve measurable change. This is because the new microbes have to displace the entrenched resident microbes. Second, there is the question of donor matching. When we treat patients with C. difficile infections, our simple objective is to restore a ‘healthy’ microbial composition in the gut. Matching is not a concern in this situation and our donor selection focuses mainly on donor health. However, we believe that more sophisticated selection of donor microbes, tailor-made for specific diseases, is needed for most conditions other than C. difficile infections that are of interest to patients. Indeed, this is what we are trying in some of our clinical trials. However, the microbiome science is still very young and we don’t have microbiome-based diagnostic tests to select the right donors for non-C. difficile indications. Therefore, basic research and clinical trials will remain critical if we’re ever to make progress in this field.

Probiotics are not therapeutics. They are not intended to treat, mitigate, or prevent disease. They have not been formally tested to treat any disease. In fact, manufacturers are disincentivized to rigorously test whether probiotics help any diseases because doing so risks their products being classified as drugs and that would prohibit sales as dietary supplements. Marketing of these products can be very seductive, but it should not be confused with very specific claims that are associated with true therapeutics. We don’t recommend probiotics for most clinical indications.

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