PERSPECTIVE article
Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1695976
This article is part of the Research TopicDecoding Microbiome-Derived Therapeutics in Non-Communicable Diseases and Aging: Science, Applications, and FutureView all articles
Not Quite a Cure Yet: Unlocking the Unfulfilled Promise of Live Biotherapeutics for Disease Treatment
Provisionally accepted
- 1The University of British Columbia Okanagan, Kelowna, Canada
- 2University of California Los Angeles Division of Digestive Diseases, Los Angeles, United States
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Few live microbial therapeutics have demonstrated conclusive or reproducible clinical efficacy. Cochrane meta-analyses of probiotic interventions across multiple clinical trials, analyzed using a rank-biserial correlation test, revealed that intestinal inflammation is negatively correlated with clinical responsiveness. This is exemplified by Escherichia coli Nissle 1917, which shows modest efficacy in maintaining remission comparable to frontline therapies, yet fails to demonstrate clear benefit in the treatment of active ulcerative colitis, an inflammatory bowel disease defined by chronic intestinal inflammation. Beyond inflammation as a key barrier to efficacy, inadequate shelf life and delivery strategies further compromise microbial viability and functional persistence in the gastrointestinal tract. Here, we highlight both the challenges and emerging opportunities in the field of live microbial therapeutics, emphasizing the urgent need to integrate scientific, clinical, and industrial efforts to achieve durable and clinically meaningful outcomes.
Keywords: Live biotherapeutic product, probiotic, Inflammation, Escherichia coli Nissle 1917 (EcN), Live microbial therapeutics
Received: 31 Aug 2025; Accepted: 17 Oct 2025.
Copyright: © 2025 Verdugo-Meza, Chiang, Mayer and Gibson. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Deanna L Gibson, deanna.gibson@ubc.ca
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