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The gut microbiome is a complex and dynamic ecosystem comprising trillions of microorganisms, including bacteria, archaea, fungi, and viruses, that reside within the human gastrointestinal tract (NIH, 2023). It serves as a critical mediator of host health by performing essential biological functions such as the fermentation of non-digestible carbohydrates into short-chain fatty acids, the synthesis of vitamins K and B12, and the regulation of the host immune system (Fan & Pedersen, 2021). Dysbiosis, characterized by a loss of microbial diversity or an overgrowth of pathobionts, is implicated in a wide range of diseases, including Clostridioides difficile infection, inflammatory bowel disease, obesity, and certain neuropsychiatric conditions (Lynch & Pedersen, 2016). Therapeutic strategies targeting the microbiome include the use of antibiotics to eliminate pathogens, probiotics and prebiotics to encourage beneficial growth, and fecal microbiota transplantation (FMT) to restore community balance. Recently, the field has shifted toward standardized microbial consortia, such as the FDA-approved fecal microbiota spores-brpk (SER-109), which provides a regulated approach to microbiome restoration (FDA, 2023). Despite its therapeutic potential, targeting the microbiome presents unique challenges, including the risk of systemic infection in immunocompromised patients and the difficulty of achieving long-term colonization of donor strains.
Restoration of microbial diversity, competitive inhibition of pathogens, and modulation of host-microbe metabolic signaling (FDA, 2023; Fan & Pedersen, 2021).
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