Using The Microbiome to Treat Disease: Great Potential, But Patients Must be Protected

According to a story from the Scientific American, new research is revealing the potential of the human microbiome as a method for treating health problems. Research is also continuing to reveal just how much impact the microbiome can have on our health. One of the most popular treatment approaches that utilizes the microbiome is fecal microbiota transplantation (FMT). While this procedure has successfully been used to treat Clostridioides difficile (C. diff) infections, a recent death associated with FMT highlights the need for better regulation and screening of approaches using the microbiome.

About The Microbiome

The microbiome describes the community of microorganisms, mostly bacteria, that survive throughout our bodies. The digestive tract is home to the greatest number and diversity of species and most research has focused on the microbiome of this area in particular. This diverse population plays a critical role in normal body processes such as digestion, and studies have found potential links to a variety of mental and physical health measures. Damage to the microbiome can often leave the body more vulnerable to disease; viral infections, antibiotic use, and stress all have the potential to disrupt the microbiome.

Patient Safety First

FMT is currently being investigated as a possible treatment for a number of other diseases. Unfortunately, the death that occurred with the procedure forced the US Food and Drug Administration (FDA) to release a safety alert. An FMT operation helps restore the patient’s microbiome and boosts their body’s own ability to fight disease. The FDA unfortunately opened the door to unregulated FMT in 2013 with an enforcement discretion policy that did not require an investigational new drug application, meaning that the approach was not subject to safety testing.

The risk comes from the fact that not everyone has stool that is suitable for donation and use in FMT. The drug company Rebiotix is making efforts to go through the appropriate channels to ensure that its microbiota-based treatments will be backed by clinical data to ensure efficacy and safety. The future of the microbiota holds great potential for human health, but it is essential that patients are safe as new approaches are developed.


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