ABSTRACT
Background Antibiotics are life-saving drugs but severely affect the gut microbiome with short term consequences including diarrhoea, Clostridium difficile infections and selection of antibiotic-resistant bacteria. Long-term links to allergy and obesity are also suggested. We devised a product, DAV132, and previously showed its ability to deliver a powerful adsorbent, activated charcoal, in the late ileum of human volunteers.
Methods We performed a randomized controlled trial (ClinicalTrials.gov NCT02176005) in 28 human volunteers treated with a 5-day clinical regimen of the fluoroquinolone antibiotic moxifloxacin in two parallel groups, with or without DAV132 co-administration. Two control goups of 8 volunteers each receiving DAV132 alone, or a non-active substitute, were added.
Results The co-administration of DAV132 decreased free moxifloxacin fecal concentrations by 99%, while plasmatic levels were unaffected. Shotgun quantitative metagenomics showed that the richness and composition of the intestinal microbiota were largely preserved in subjects co-treated with DAV132 in addition to moxifloxacin. No adverse effect was observed. In addition, DAV132 efficiently adsorbed a wide range of clinically relevant antibiotics ex-vivo.
Conclusions DAV132 was highly effective to protect the gut microbiome of moxifloxacin - treated healthy volunteers and may constitute a clinical breakthrough by preventing adverse health consequences of a wide range of antibiotic treatments.
Footnotes
Potential conflicts of interest: AD, FSG, VA and MV are employees of Da Volterra. JG, ER, CB, EC, FM and AA are consultants for Da Volterra. JG, AD, FSG and VA are shareholders of Da Volterra. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.
Financial support: The randomised clinical trial was sponsored by Da Volterra (Paris) and funded in part by the European Union Seventh Framework Programme (FP7-HEALTH-2011-single-stage) under grant agreement n° 282004, EvoTAR. Additional funding was from the Metagenopolis grant ANR-11-DPBS-0001, and from BPIFrance under the NOSOBIO collaborative programme.
