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Clostridioides Difficile Controlled Human Infection Model

NCT06702345 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-22

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Helmholtz Centre for Infection Research

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Oxford

    collaborator OTHER

  • University of Cologne

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-07-01
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702345 on ClinicalTrials.gov