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The intestinal microbiome composition and function refers to the complex community of trillions of microorganisms, including bacteria, fungi, and viruses, residing in the human gastrointestinal tract and their collective metabolic activities (NIH, 2012). This ecosystem is fundamental to human health, performing essential roles such as the fermentation of dietary fibers into short-chain fatty acids, the synthesis of vitamins K and B12, and the regulation of the host immune system (Nature Reviews Microbiology, 2021). Dysbiosis, characterized by a loss of microbial diversity or an overgrowth of pathogenic species, is strongly associated with diseases like Clostridioides difficile infection, inflammatory bowel disease, and obesity (Cell, 2018). Therapeutic strategies targeting the microbiome include fecal microbiota transplantation (FMT), live biotherapeutic products (LBPs) like SER-109, and prebiotics, which aim to restore ecological balance and functional output (FDA, 2022). Despite its therapeutic potential, the microbiome's complexity and high inter-individual variability pose significant challenges for drug standardization and the prediction of long-term safety outcomes (Science, 2019).
Modulation of microbial diversity, competitive exclusion of pathogens, and production of bioactive metabolites such as short-chain fatty acids (SCFAs) that interact with host receptors (Nature Reviews Microbiology, 2021).
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