Establishing colonisation with non-toxigenic Clostridioides difficile in healthy volunteers.
- Conditions
- experimental human NTCD colonisation1001796610004018
- Registration Number
- NL-OMON56374
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
1. Subject is aged >= 18 and <= 45 years and in good health.
2. Subject has adequate understanding of the procedures of the study and is
able and willing to abide strictly thereby.
3. For female subjects: subject agrees to use adequate contraception and not to
breastfeed for the duration of study.
4. Subject has signed informed consent.
1. 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.
2. Use of antibiotics (or other microbiota influencing products) within three
months prior to inclusion.
3. 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).
4. Regular use (defined by more than once weekly) of proton-pump inhibitors or
H2- blockers during one month prior to inclusion.
5. The use of strong P-glycoprotein-inhibitors (like ciclosporin, ketoconazole,
erythromycin, clarithromycin, verapamil and amiodaron).
6. Known allergy to vancomycin, metronidazole or fidaxomicin.
7. Known allergy to glycerol.
8. Known immunodeficiency disorders.
9. Known gastro-intestinal disease including but not limited to inflammatory
bowel diseases (Crohn*s disease, Colitis Ulcerosa), recent gastro-intestinal
surgery, constipation defined by bowel movements less than every second day.
10. Positive fecal PCR with Clostridiodes or SSYC (Salmonella, Shigella,
Yersinia or Campylobacter spp.) at screening.
11. Any condition that would put household members at a greater risk for
transmission e.g. no access or use of flush toilet, household members belonging
to vulnerable populations such as persons who are immunocompromised, children
younger than 2 years of age and elderly older than 70 years of age.
12. For women of child bearing potential: a positive urine pregnancy test
before inclusion or lactating at screening / during the trial.
13. Being an employee or student of the Experimental bacteriology group or the
controlled human infection center at LUMC.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Number and grade of adverse events during the first month after ingestion of<br /><br>spores of non-toxigenic C.difficile.<br /><br>- The number of volunteers successfully colonised with non-toxigenic<br /><br>C.difficile. Colonisation is defined as a positive PCR for C.difficile on stool<br /><br>or a positive culture for C.difficile on at least two timepoints between three<br /><br>days and two weeks after the last exposure day. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Microbiota markers which are associated with successful C.difficile<br /><br>colonisation.<br /><br><br /><br>Exploratory endpoints<br /><br>- Identification of changes in microbiota components following C.difficile<br /><br>colonisation.<br /><br>- Identification of genetic changes in C.difficile after passage through the<br /><br>human host.</p><br>