Clostridioides Difficile Colonisation

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 and host microbiota factors associated with colonisation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

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.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

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 within one month 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 culture or 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 serological pregnancy test at screening 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.