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Escherichia coli lipopolysaccharide, also known as lipopolysaccharide from E. coli 0113, is a structurally diverse substance originally derived from the outer membrane of certain Escherichia coli bacteria.[3] It is classified in the therapeutic area of immune system processes and is used experimentally to provoke a controlled inflammatory response in humans.[1] LPS has no marketing authorisation in the product records and is therefore an investigational substance, supplied in research settings by Stichting Radboud University Medical Center.[1] In the registered trial it serves as an auxiliary agent, meaning it is used to create the experimental condition rather than being tested as a treatment itself.[1]
Lipopolysaccharide is a major component of the outer membrane of Gram-negative bacteria such as E. coli. When introduced into the bloodstream, it is recognised by the immune system as a bacterial signal and triggers a strong inflammatory response, a state referred to as endotoxemia.[2] Research has shown that E. coli can use LPS as a decoy to impair the movement of neutrophils, a type of immune cell, and thereby weaken antimicrobial host defence.[2] In the DEDICATE-LPS study, a repeated endotoxemia model in healthy volunteers was used to investigate how different anti-inflammatory drugs modify this LPS-driven immune response.[1]
Escherichia coli lipopolysaccharide is not used to treat a disease. It is studied as a tool to understand and modify the body's inflammatory response.
In the registered trial, escherichia coli lipopolysaccharide from E. coli 0113 is given as a solution for injection by intravenous injection.[1] The substance data record lists the pharmaceutical form as solution for injection and the route of administration as intravenous injection.[1]
One completed trial is registered for escherichia coli lipopolysaccharide. The DEDICATE-LPS study (2023-506556-24-00) is a Phase 2 interventional trial that enrolled 52 healthy volunteers.[1] The trial investigated the immunomodulatory effects of three drugs — dexamethasone, tocilizumab and anakinra — on the development of immunoparalysis in a repeated endotoxemia model in humans.[1] Immunoparalysis is a state of reduced immune responsiveness that can follow a strong inflammatory stimulus. The primary outcome was the between-group difference in plasma TNF concentrations upon the second LPS challenge, where TNF is a key signalling molecule of inflammation.[1] The study also included comparison arms with sodium chloride solutions, atropine and lidocaine.[1]
The supplementary sources provided do not report specific side effects of escherichia coli lipopolysaccharide in the context of this trial. The experimental model itself involves inducing a temporary inflammatory response in healthy volunteers, which is the intended effect of the substance in this research setting.[1]
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