Who is sponsoring NCT05693077?

NCT05693077 is sponsored by Leiden University Medical Center.

What drugs are being tested in NCT05693077?

Interventions in NCT05693077: 10E4 NTCD spores, 10E7 NTCD spores, placebo, Vancomycin Oral Capsule.

What condition does NCT05693077 study?

NCT05693077 studies Clostridioides Difficile Infection.

Is NCT05693077 still recruiting?

NCT05693077 is currently status unknown. Last updated 16 October 2023.

Last reviewed 2023-10-16 · How we verify

NCT05693077: CloDiCo

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Establishing Colonisation With Non-toxigenic Clostridioides Difficile in Healthy Volunteers

Status unknown Phase 1 Last updated 16 October 2023

What this trial tests

Phase 1 trial testing 10E4 NTCD spores in Clostridioides Difficile Infection in 70 participants. Status unknown.

Timeline

22 September 2023

Primary endpoint
1 June 2024

1 June 2025

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	70
Start date	22 September 2023
Primary completion	1 June 2024
Estimated completion	1 June 2025
Sites	1 location across Netherlands

Drugs / interventions tested

10E4 NTCD spores — full drug profile →
10E7 NTCD spores — full drug profile →
placebo
Vancomycin Oral Capsule

Conditions studied

Clostridioides Difficile Infection — all drugs for Clostridioides Difficile Infection →

Sponsor

Leiden University Medical Center

Who can join

Adults 18 to 45, any sex, with Clostridioides Difficile Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety and tolerability of colonisation with non-toxigenic C.difficile
Time frame: During the first month after ingestion of NTCD spores.
Number and grade of related adverse events from day 1 to 28 after ingestion of NTCD spores.
To establish the effective protocol to obtain colonisation with non-toxigenic C. difficile in the majority of subjects.
Time frame: During the first month after ingestion of NTCD spores.
The number of volunteers successfully colonised with non-toxigenic C.difficile. Colonisation is defined as a positive PCR for C.difficile on stool or a positive culture for C.difficile on at least two timepoints between three days and two weeks after the last exposure day.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Microbiota-Based Live Biotherapeutic Products for Clostridioides Difficile Infection- The Devil is in the Details.
Monday L, Tillotson G, Chopra T. · · 2024 · cited 9× · PMID 38375101 · DOI 10.2147/idr.s419243
Bacterial live therapeutics for human diseases.
Frutos-Grilo E, Ana Y, Gonzalez-de Miguel J, Cardona-I-Collado M, et al · · 2024 · cited 6× · PMID 39443745 · DOI 10.1038/s44320-024-00067-0
Characterization of the clade 4 non-toxigenic C. difficile isolate L-NTCD03 carrying the cfr(B) gene.
Nibbering B, Nooij S, Harmanus C, Sanders IMJG, et al · · 2026 · PMID 41783251 · DOI 10.1093/femsmc/xtag010
Manufacture of Clostridioides difficile Spores for Experimental Infection of Human Volunteers.
Hensen ADO, Harmanus C, Voorvelt C, Geelen AR, et al · · 2026 · PMID 41360073 · DOI 10.1093/infdis/jiaf612

Verify or expand the search:

Other recruiting trials for Clostridioides Difficile Infection

Currently open trials in the same condition.

NCT07285213 — Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody · Phase 2 · recruiting
NCT06979609 — Secondary Prevention of Clostridioides Difficile Using Vancomycin · Phase 2, PHASE3 · recruiting
NCT06859437 — Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantati · NA · recruiting
NCT05330182 — LMN-201 for Prevention of C. Difficile Infection Recurrence · Phase 2, PHASE3 · recruiting
NCT06788769 — Study of Clostridioides Difficile in Infants · recruiting

Other Leiden University Medical Center trials

Trials by the same sponsor.

NCT07312565 — Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage · not yet recruiting
NCT07090343 — Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement · Phase 3 · not yet recruiting
NCT07498738 — Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions · NA · not yet recruiting
NCT06545292 — Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients · NA · recruiting
NCT07021495 — SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05693077 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Leiden University Medical Center
Last refreshed: 16 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05693077.

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