Clostridioides Difficile Controlled Human Infection Model (NCT06702345) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clostridioides Difficile Controlled Human Infection Model
Netherlands60 participantsStarted 2025-03-01
Plain-language 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.
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;
✓. Body mass index (BMI) ≥18.0 and \<30.0 kg/m2;
✓. Subject has adequate understanding of the procedures of the study and is able and willing to abide strictly thereby;
✓. Subject is able to communicate well with the investigator, is willing to follow hygienic measures and instructions;
✓. For women of childbearing potential: subject agrees to use adequate contra-ception (see Appendix D for the different adequate contraception methods for this study) and not to breastfeed for the duration of the study;
✓. Subject has signed informed consent.
Exclusion criteria
✕. Any physical or psychiatric illness or conditions that could threaten or com-promise the health of the subject during the study, influence their ability to par-ticipate in the trial or interfere with the interpretation of the study results, as de-termined by the trial physician;
✕. Use of systemic (IV or oral) antibiotics within three months prior to screening; other microbiota influencing medication (that could influence the trial, based on the Investigator's opinion) within 1 month prior to screening visit. Prior use of topical antibiotics is permitted if there is no clinically relevant systemic ex-pected following assessment of the trial physician and are expected to be dis-continued during the start of the first study activity.
What they're measuring
1
Safety of exposure to toxigenic C. difficile spores with optional antibiotic pretreatment
Timeframe: from day 0 until day 35 for cohort A and from day -5 until day 35 for cohort B and C.
2
Colonisation with the challenge C. difficile strain
Timeframe: on at least two timepoints from day 14 until day 35
✕. Has had a recent hospitalization (e.g. 3 months prior to screening) and/or has someone in immediate social circle who is frequently hospitalized (≥3 times in a 12-month period) or frequently exposed to hospital settings (≥ one time a month, e.g. dialysis units);
✕. Regular use (defined by more than once weekly) of proton-pump inhibitors or H2-blockers during one month prior to screening;
✕. Chronic use of immunosuppressive drugs, e.g. systemic corticosteroids or other immune modifying drugs (with exception of oral anti-histamines and top-ical/inhaled corticosteroids);
✕. Positive HIV, Hepatitis B or C screening tests;
✕. Known immunodeficiency disorders;
✕. The use of strong P-glycoprotein-inhibitors (like ciclosporin, ketoconazole, erythromycin, clarithromycin, verapamil and amiodaron) during the trial;