Methods
DAV132, containing activated charcoal, was administered to healthy volunteers alongside moxifloxacin (MXF) to assess its protective effects on the gut microbiome. The study was a randomized, controlled trial conducted in compliance with Good Clinical Practice and the Declaration of Helsinki.
Results
- MXF Pharmacokinetics: DAV132 reduced fecal MXF concentrations by over 99% without significantly affecting plasma levels, indicating targeted action in the gut.
- Microbiome Protection: The richness and composition of the intestinal microbiota were largely preserved in volunteers receiving DAV132 with MXF, compared to those receiving MXF alone.
- Safety: DAV132 was well tolerated, with no serious adverse effects reported, and did not interfere with the systemic therapeutic effects of MXF.
- Broad Antibiotic Adsorption: DAV132's activated charcoal effectively adsorbed a wide range of antibiotics in ex vivo conditions, suggesting its potential applicability beyond MXF.
Discussion
The study highlights DAV132's potential as a breakthrough product for protecting the gut microbiome from the detrimental effects of antibiotics. Its ability to adsorb various antibiotics without affecting their systemic efficacy positions DAV132 as a promising candidate for further clinical evaluation to prevent antibiotic-associated dysbiosis and its long-term consequences.
