Gut Microbiome Related to Depression: Regulatory Implications
(Thursday, December 10, 2020]​
Gut microbiome has been suggested to be linked to several diseases seemingly unrelated to the digestive system with the scientific literature rife with anecdotes and poorly designed studies. A report published this week provides a novel approach to establish microbiome-disease relationship that, in turn, could provide a scientific strategy to generate critical data for regulatory acceptance of other such products. To evaluate the relationship between the gut microbiome and major depressive disorder, researchers compared the microbiota of equal number of healthy individuals and patients with diagnosed non-medicated major depressive disorder (MDD). Microbiome characterization data from a total of 236 participants; 118 healthy and 118 MDD patients, showed several characteristic differences in the microbiomes of the two sets of volunteers. It was found that the two populations differed in the contents of 47 bacterial subtypes and three bacteriophage species. Further analysis of the compounds generated by the microbiome showed differences in 50 metabolites or molecules between healthy and patient populations. The team could use this information to generate a biomarker panel that was able to identify people with MDD around 90 percent of the time. This strategy can be extrapolated to evaluate other similar relationships between the gut microbiome and diseases. The gut microbiome has been compared to the genetic profile of an individual. An individual’s microbiome profile can be used, just like their genetic profile, for predictive, prognostic, and therapeutic purposes, leading to medical applications. So far, microbiome-based products have been developed and marketed as dietary supplements, probiotics, and medical foods for lack of FDA-acceptable scientific rationale for such products. Experiments of the type described here are critical to get regulatory acceptance of these products as live biotherapeutics. This report provides a roadmap to evaluate microbiome profiles of diverse groups to build the rationale for a given bacterial panel for a given medical application.