Abstract
Urinary tract infections (UTIs) are very common disorders that affect adult women. Indeed, 50% of all women suffer from UTIs at least one time in their lifetime; 20–40% of them experience recurrent episodes. The majority of UTIs seems to be due to uropathogenic Escherichia coli that invades urothelial cells and forms quiescent bacterial reservoirs. Recurrences of UTIs are often treated with non-prescribed antibiotics by the patients, with increased issues connected to antibiotics resistance. D-mannose, a monosaccharide that is absorbed but not metabolized by the human body, has been proposed as an alternative approach for managing UTIs since it can inhibit the bacterial adhesion to the urothelium. This manuscript discusses the mechanisms through which D-mannose acts to highlight the regulatory aspects relevant for determining the administrative category of healthcare products placed on the market. The existing literature permits to conclude that the anti-adhesive effect of D-mannose cannot be considered as a pharmacological effect and, therefore, D-mannose-based products should be classified as medical devices composed of substances.
Highlights
Urinary tract infections (UTIs) are very common disorders affecting adult women
D-mannose is absorbed, but not metabolized by the human body and it is excreted intact in urine
Neither ancillary effects on bacteria, nor urothelium have been reported in the literature yet
Summary
Urinary tract infections (UTIs) are very common disorders affecting adult women. In the United States, 11% of women report at least one UTI event per year (Hickling and Nitti, 2013). If urine contains sufficiently high levels of free D-mannose to saturate the FimH adhesin of UPEC, bacteria are unable to grapple onto the epithelial cells and are flushed away by shear forces due to the urinary flow (Ofek et al, 1982; Schwartz et al, 2013) Starting from such scientific evidence, D-mannose and its derivatives (e.g., α-D-mannosides) have been investigated as non-antibiotic prevention strategies for both acute and recurrent UTIs (Kranjcec et al, 2014; Porru et al, 2014; Domenici et al, 2016; Phé et al, 2017; Parrino et al, 2019; Mainini et al, 2020). Due to this physical mechanism of action, D-mannose has a negligible risk of developing bacterial resistance, unlike antibiotics (Sarshar et al, 2020; Scribano et al, 2020)
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