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Clostridioides Difficile Colonisation

NCT05693077 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-17

No results posted yet for this study

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 to ultimately determine host microbiota factors associated with susceptibility to colonisation.

Conditions

  • Clostridioides Difficile Infection

Interventions

BIOLOGICAL

10E4 NTCD spores

in capsule for oral ingestion.

BIOLOGICAL

10E7 NTCD spores

in capsule for oral ingestion.

OTHER

placebo

in capsule for oral ingestion.

DRUG

Vancomycin Oral Capsule

4 times a day 250mg

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Meta Roestenberg, MD, PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693077 on ClinicalTrials.gov