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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Subject is aged ≥ 18 and ≤ 45 years and in good health.
✓. Subject has adequate understanding of the procedures of the study and is able and willing to abide strictly thereby.
✓. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
✓. Subject has signed informed consent.
Exclusion criteria
✕. Any physical or psychiatric illness or conditions that could threaten or compromise the health of the subject during the study, influence their ability to participate in the trial or interfere with the interpretation of the study results, as determined by the trial physician.
✕. Use of antibiotics (or other microbiota influencing products) within one month prior to inclusion.
✕. Known immunosuppressive condition, including infection with Human Immunodeficiency Virus (HIV), use of systemic corticosteroids or other immune modifying drugs (with exception of antihistamines and topical steroids).
✕. Regular use (defined by more than once weekly) of proton-pump inhibitors or H2- blockers during one month prior to inclusion.
✕. The use of strong P-glycoprotein-inhibitors (like Ciclosporin, Ketoconazole, Erythromycin, Clarithromycin, Verapamil and Amiodaron).
✕. Known allergy to vancomycin, metronidazole or fidaxomicin.
✕
What they're measuring
1
Safety and tolerability of colonisation with non-toxigenic C.difficile
Timeframe: During the first month after ingestion of NTCD spores.
2
To establish the effective protocol to obtain colonisation with non-toxigenic C. difficile in the majority of subjects.
Timeframe: During the first month after ingestion of NTCD spores.