Experimental human colonisation with non-toxigenic Clostridioides difficile: a placebo-controlled randomised clinical trial - PubMed
3 hours ago
- #Clostridioides difficile
- #Clinical trial
- #Microbiota disruption
- Experimental human colonization with non-toxigenic Clostridioides difficile (NTCD) was tested in a placebo-controlled randomized clinical trial to assess safety, colonization success, and microbiota susceptibility.
- The trial involved 69 healthy participants aged 18-45, with no prior C. difficile colonization or recent antibiotic use, who received NTCD capsules at low or high doses for five days, finding the treatment safe and without a dose-response in colonization outcomes.
- Vancomycin pretreatment significantly increased colonization success: 5% without pretreatment, 32% after one day, and 84% after five days, indicating the impact of antibiotic-mediated microbiota disruption.
- Some participants rapidly cleared vancomycin and acquired non-challenge C. difficile strains before NTCD challenge, highlighting widespread environmental presence of the bacteria.
- Microbiota profiling via shotgun metagenomics showed reduced α-diversity and community restructuring, demonstrating feasibility of microbiota assessment in small-scale trials for insights into C. difficile infections.