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Microbiome-Based Therapeutics in Digestive Diseases: What They Are and How Are They Regulated
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Microbiome-Based Therapeutics in Digestive Diseases: What They Are and How Are They Regulated
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Journal Article
Microbiome-Based Therapeutics in Digestive Diseases: What They Are and How Are They Regulated
2023
Overview
The “microbiome” is colloquially taken to mean the relative abundance of the genera and species that constitute the gut bacteria (“taxonomy”); however, the microbiome in its broadest sense encompasses bacterial taxonomy, gut fungi (“mycobiome”) and viruses (“virome”), and the totality of their functional and metabolic state (2,5,6). Any agent that modifies this ecology can be considered an MBT. [...]we believe that an MBT used for therapeutic intent to treat specific human diseases should be regulated by the US FDA and require an IND before clinical trial. Author Notes Correspondence: Shrinivas Bishu, MD. Email: bishus@med.umich.edu REFERENCES 1.Fan, Y, Pedersen, O. Gut microbiota in human metabolic health and disease.
Publisher
Wolters Kluwer,Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
Subject
