drugset / Trial / NCT05693077

Clostridioides Difficile Colonisation

NCT05693077

Phase 1 Unknown 70 enrolled Leiden University Medical Center
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study will investigate experimental colonisation with non-toxigenic C.difficile (NTCD) in healthy volunteers. Main outcomes will be safety, tolerability, dose needed to obtain colonisation with NTCD to ultimately determine host microbiota factors associated with susceptibility to colonisation.

Timeline

Start
2023-09-22
Primary completion
2024-06
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Subject 10E4 NTCD spores Unknown Oral
Subject 10E7 NTCD spores Unknown Oral
Background Vancomycin Other / unclassified 250 mg Oral