Clostridioides Difficile Controlled Human Infection Model

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

December 31, 2026

Conditions
C. DifficileC. Difficile InfectionControlled Human Infection
Interventions
OTHER

encapsulated 10^4 CFU toxigenic. C. difficile spores

12 consecutive days of once a day a capsule with 10\^4 CFU toxigenic C. difficile spores.

DRUG

Vancomycin

oral vancomycin pretreatment, 4 times a day 250mg, given the five days before toxigenic C. difficile exposure.

DRUG

Clindamycin

oral clindamycin pretreatment, 3 times a day 600mg, given the five days before toxigenic C. difficile exposure

Trial Locations (1)

2333ZA

Leiden University Medical Center, Leiden

All Listed Sponsors
collaborator

Helmholtz Centre for Infection Research

OTHER

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

University of Oxford

OTHER

collaborator

University of Cologne

OTHER

lead

Leiden University Medical Center

OTHER