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Clinical Development

New Whitepaper: The Microbiome in Clinical Trials – Opportunities and Challenges

  • November 30, 2017
The Microbiome in Clinical Trials

The human microbiome is elaborate and dynamic. Composed of microbial cells in direct contact with the human body, the microbiome covers us inside and out like a cloud and plays a role in radically different areas of health, such as nutrition, early childhood development, hygiene, infectious diseases, and chronic health conditions.

Until just recently only about 20% of the bacteria in our body had ever been cultured, partly because there was really no pressing need to identify everything. Most of the time we live in harmony or symbiosis with these microbes, so medicine and microbiology had historically focused on those organisms that were identified to trigger disease and have the potential to quickly kill us. It is now better understood that other organisms, including some that have previously been thought to be innocent bystanders, have a more subtle way of interacting with us. New concepts on what is normal and what is not are advancing our understanding of microbes as not only part of a human but important in influencing our health and behaviors as humans. In turn, these microbes are influenced by our health and behavior, leading to a very complicated and interactive ecosystem. Based on its size, organization, and specialized functions, many now consider the microbiome as a distinct organ that carries out activities essential to our well-being.

Altering the microbiome to treat or decrease the risk of disease may be done more easily than finding therapeutics that rewrite the human genes that have been linked to a certain disease. As some have said, the microbiome is the only “organ” that can be replaced without surgery. Consequently, multiple clinical studies are underway that are testing single commensals, mixtures of defined species and subspecies, and cocktails of microbiota-derived molecules targeting specific microbial species or pathways that are enriched or absent in the disease state in an effort to treat or prevent a variety of diseases.

Read the Full Whitepaper on the Microbiome and Clinical Research

Infectious disease experts from Medpace and Diversigen discuss the opportunities and challenges of the microbiome in clinical trials in a recently published whitepaper. They illustrate the concept of how the microbiome may be altered to treat disease using the example of Clostridium difficile (C. diff) and the gut microbiota. You can access the whitepaper in its entirety here.