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, Vincenzo Ficarra, Marco Gobbi, Kurt Naber, Huub Schellekens

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract

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. PRISMA systematic review approach was applied; Delphi Panel method was used to target consensus on statements retrieved from evidence. Based on regulatory definitions and research evidence, the mechanism of D-mannose does not involve a metabolic or immunological action while there is 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. On the basis of current regulation, the uncertainty as regard a pharmacological action of alpha-D-mannose makes possible its 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.

Original languageEnglish
Pages (from-to)1153-1166
Number of pages14
JournalTherapeutic Innovation and Regulatory Science
Volume57
Issue number6
DOIs
Publication statusPublished - Nov 2023

Keywords

  • D-mannose
  • Delphi consensus
  • FimH adhesin
  • Product classification
  • Urinary tract infection

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this