Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for Its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence

Francesco Scaglione; Paola Minghetti; Francesco Ambrosio; Beat Ernst; Vicenzo Ficarra; Marco Gobbi; Kurt Naber; Huub Schellekens

doi:10.20944/preprints202301.0234.v2

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preprints.org > biology and life sciences > immunology and microbiology > doi: 10.20944/preprints202301.0234.v2

Preprint Review Version 2 Preserved in Portico This version is not peer-reviewed

Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for Its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence

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Version 1 : Received: 10 January 2023 / Approved: 13 January 2023 / Online: 13 January 2023 (03:30:36 CET)
Version 2 : Received: 20 March 2023 / Approved: 21 March 2023 / Online: 21 March 2023 (03:42:04 CET)

A peer-reviewed article of this Preprint also exists.

Scaglione, F.; Minghetti, P.; Ambrosio, F.; Ernst, B.; Ficarra, V.; Gobbi, M.; Naber, K.; Schellekens, H. Nature of the Interaction of Alpha-D-Mannose and Escherichia Coli Bacteria, and Implications for Its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence. Therapeutic Innovation & Regulatory Science 2023, doi:10.1007/s43441-023-00548-8. Scaglione, F.; Minghetti, P.; Ambrosio, F.; Ernst, B.; Ficarra, V.; Gobbi, M.; Naber, K.; Schellekens, H. Nature of the Interaction of Alpha-D-Mannose and Escherichia Coli Bacteria, and Implications for Its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence. Therapeutic Innovation & Regulatory Science 2023, doi:10.1007/s43441-023-00548-8.

Abstract

Background: the nature of alpha-D-mannose - natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing urinary tract infections - in the interaction with E. coli is addressed in order to drive the issue of its regulatory classification as a medicinal product or medical device. Methods: PRISMA systematic review approach was applied; Delphi Panel method used to target consensus on statements retrieved from evidence. Results: Based of regulatory definitions and research evidences, the mechanism of D-mannose does not involve a metabolic or immunological action while there is an uncertainty regarding the pharmacological action. Specific interaction between the product and the bacteria within the body occurs, but its nature is inert: it does not induce a direct response activating or inhibiting body processes. Moreover, the action of D-mannose takes place, even if inside the bladder, outside the epithelium on bacteria that have not yet invaded the urothelial tissue. Therefore, its mechanism of action is not directed to host structures but to structures (bacteria) external to the host's tissues. Conclusions: From a regulatory perspective, D-mannose maintains the current medical device classification: new regulations and legal judgments can add further considerations. From a pharmacological perspective, research is driven versus synthetic mannosides: no further considerations are expected on alpha-D-mannose.

Keywords

D-mannose; urinary tract infection; FimH adhesin; product classification

Subject

Biology and Life Sciences, Immunology and Microbiology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Comments (1)

Comment 1

Received: 21 March 2023
Commenter: Stefania Lopatriello
Commenter's Conflict of Interests: Author

Comment: manuscript rewording due to overlap check

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