Microbiota-directed biotherapeutics: considerations for quality and functional assessment

Mounting evidence points to causative or correlative roles of gut microbiome in the development of a myriad of diseases ranging from gastrointestinal diseases, metabolic diseases to neurological disorders and cancers. Consequently, efforts have been made to develop and apply therapeutics targeting the human microbiome, in particular the gut microbiota, for treating diseases and maintaining wellness. Here we summarize the current development of gut microbiota-directed therapeutics with a focus on novel biotherapeutics, elaborate the need of advanced -omics approaches for evaluating the microbiota-type biotherapeutics, and discuss the clinical and regulatory challenges. We also discuss the development and potential application of ex vivo microbiome assays and in vitro intestinal cellular models in this context. Altogether, this review aims to provide a broad view of promises and challenges of the emerging field of microbiome-directed human healthcare.

Automated summary

Mounting evidence suggests that the gut microbiome plays a causative or correlative role in various diseases, such as gastrointestinal diseases, metabolic diseases, neurological disorders, and cancers. Therefore, there have been efforts to develop and apply therapies that target the gut microbiota for disease treatment and wellness maintenance. This review summarizes the current development of gut microbiota-directed therapeutics, emphasizes the importance of advanced -omics approaches for evaluating microbiota-type therapies, and discusses the clinical and regulatory challenges. It also explores the development and potential application of ex vivo microbiome assays and in vitro intestinal cellular models. Overall, this review provides a comprehensive view of the promises and challenges in the emerging field of microbiome-directed human healthcare.