Clostridioides Difficile Controlled Human Infection Model
Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
This study will investigate in healthy study subjects, the safety and tolerability of a controlled infection with Clostridioides difficile, a gut bacterium that can cause diarrhoea. It is also examined which dosing regimen (with or without antibiotic pretreatment) is required to induce mild symptoms (like diarrhoea) in the majority of study subjects and which microbiota and immunological factors influence this.
To investigate this, healthy adult study subjects will be asked to ingest capsules (pills) containing the Clostridioides bacterium.
Phase:
NA
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
GlaxoSmithKline Helmholtz Centre for Infection Research University of Cologne University of Oxford