Clostridioides Difficile Controlled Human Infection Model
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
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;
Trial design
Treatments tested in this trial
- encapsulated 10^4 CFU toxigenic. C. difficile spores
- Vancomycin
- Clindamycin
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Leiden University Medical Center
Lead sponsor
Helmholtz Centre for Infection Research
Collaborator
GlaxoSmithKline
Collaborator
University of Oxford
Collaborator
University of Cologne
Collaborator
Source ClinicalTrials.gov