Da Volterra, Paris, France.
Metagenopolis, Institut National de la Recherche Agronomique, Jouy-en-Josas, France.
J Infect Dis. 2018 Jan 30;217(4):628-636. doi: 10.1093/infdis/jix604.
Antibiotics are life-saving drugs but severely affect the gut microbiome with short-term consequences including diarrhea 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.
We performed a randomized controlled trial in 28 human volunteers treated with a 5-day clinical regimen of the fluoroquinolone antibiotic moxifloxacin in 2 parallel groups, with or without DAV132 coadministration. Two control goups of 8 volunteers each receiving DAV132 alone, or a nonactive substitute, were added.
The coadministration 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.
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.
NCT02176005.
抗生素是救命药物，但会严重影响肠道微生物群，导致短期后果，包括腹泻和抗生素耐药菌的选择。长期以来，抗生素与过敏和肥胖也有联系。我们设计了一种产品 DAV132，并已证明其能在人类志愿者的回肠末端输送一种强效的吸附剂——活性炭。
我们在 28 名志愿者中进行了一项随机对照试验，这些志愿者接受了为期 5 天的氟喹诺酮类抗生素莫西沙星的临床治疗方案，分为两组，一组同时给予 DAV132，另一组不给予。另外还设立了两组对照，每组 8 名志愿者，分别给予 DAV132 或非活性替代物。
DAV132 的联合使用使粪便中游离莫西沙星的浓度降低了 99%，而血浆水平不受影响。 shotgun 定量宏基因组学显示，在莫西沙星联合 DAV132 治疗的受试者中，肠道微生物群的丰富度和组成在很大程度上得以保留。未观察到不良反应。此外，DAV132 能有效地吸附广泛的临床相关抗生素。
DAV132 对保护莫西沙星治疗的健康志愿者的肠道微生物群非常有效，可能通过预防广泛的抗生素治疗的不良健康后果，成为一种临床突破。
NCT02176005。
