FDA cautions on fecal transplants

June 17, 2019

Diets aren’t the only trends in the health and wellness industry.  Medications and treatments also have their moment to shine.  The recent excitement around the microbiome and the potential to harness it to treat or even cure illnesses led to a large number of probiotic products.  It also led to a renewed interest in fecal microbiota transplants (FMT).  FMT in one form or another have been used for centuries.  The idea being to re-seed the gut with good bacteria, just like with probiotics.  The difference is that with FMT, the good bacteria are collected from the stool of healthy volunteers.

In the United States, FMTs are used as a last resort to treat patients with uncontrollable diarrhea from Clostridium difficile (commonly known as C. diff).  It’s recommended as a last resort treatment because the safety and efficacy have yet to be shown in well controlled clinical trials.  FMT is currently a risky, experimental treatment.  As of this writing, ClinicalTrials.gov lists 184 active, recruiting, or soon to be recruiting clinical trials involving fecal microbiota transplantation.  The conditions to be studied in these trials range from the expected, like Crohn’s disease, IBS, and obesity, to the surprising, like rheumatoid arthritis and Parkinson’s disease.

A number of the trials are halted after the news broke of a patient’s death.  The Food and Drug Administration (FDA) has released minimal details.  The report states that two adult patients who received FMT were immunocompromised.  Both patients received material from the same donor.  After the patients fell ill, other samples from that donor were tested.  The samples came back positive for a multi-drug resistance organism known as extended-spectrum beta-lactamase producing E.coli.   Multi-drug resistant bacteria can be deadly, especially for individuals with a compromised immune system. Unfortunately, that was the case for one of the two patients.  No information has been released about the second patient or which clinical trial the patients were enrolled in.

FMT has tremendous potential, but we are clearly still learning how to safely and effectively harness that potential.  As with any experimental treatment, it is imperative to understand the risks and weigh them against the benefits.  In weighing the risks and benefits, don’t give into the hype around new or experimental medications and treatments.  Have an open conversation with your health care team.  One of the most important questions to ask is what are the unknowns about a new medication or treatment.  Follow the ETP blog for insights on new medications and treatments that are on the horizon.  Arm yourself with knowledge and advocate for your health.




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