drugset / Trial / NCT06702345
Clostridioides Difficile Controlled Human Infection Model
Not yet recruiting
60 enrolled
Leiden University Medical Center
GlaxoSmithKline · collabHelmholtz Centre for Infection Research · collabUniversity of Cologne · collabUniversity of Oxford · collab
Non-randomizedSequentialOpen-labelPrevention
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.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2026-07-01
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clindamycin | Unknown | 600 mg | Oral |
| Subject | Vancomycin | Other / unclassified | 250 mg | Oral |