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NOT YET RECRUITING
NCT06702345
NA

Clostridioides Difficile Controlled Human Infection Model

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

Official title: Establishing a Clostridioides Difficile Controlled Human Infection Model

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-03-01

Completion Date

2026-12-31

Last Updated

2024-11-22

Healthy Volunteers

Yes

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

Locations (1)

Leiden University Medical Center

Leiden, South Holland, Netherlands