Microbiota-directed biotherapeutics: considerations for quality and functional assessment

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Fekete, Emily Ef, Figeys, Daniel and Zhang, Xu (2023) Microbiota-directed biotherapeutics: considerations for quality and functional assessment. Gut Microbes, 15 (1). pp. 1-26. ISSN 1949-0976

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Abstract

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.

Item Type: Article
Additional Information: We gratefully acknowledge Dr. Simon Sauvé, Dr. Michael Rosu-Myles, Dr. Huixin Lu, Dr. Eric Deneault, Dr. Deepak Sharma, and Dr. Allison Sherratt from Health Canada for critical comments and edits on the manuscript.
Uncontrolled Keywords: biotherapeutics,metaproteomics,microbiome assay,microbiota,multi-omics,microbiology,microbiology (medical),gastroenterology,infectious diseases,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2400/2404
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
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Depositing User: LivePure Connector
Date Deposited: 06 Mar 2026 16:30
Last Modified: 09 Mar 2026 16:31
URI: https://ueaeprints.uea.ac.uk/id/eprint/102246
DOI: 10.1080/19490976.2023.2186671

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