NCT05816577 (SECONI) is a Phase 1 clinical trial of EcN Colibactin knockout in Diabetes, sponsored by Max Nieuwdorp.

Who is sponsoring NCT05816577?

NCT05816577 is sponsored by Max Nieuwdorp.

What drugs are being tested in NCT05816577?

Interventions in NCT05816577: EcN Colibactin knockout, E Coli Nissle.

Is NCT05816577 still recruiting?

NCT05816577 is currently completed. Last updated 23 May 2024.

Last reviewed 2024-05-23 · How we verify

NCT05816577: SECONI

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

Safety and Viability of an E. Coli Nissle Colibactin Knockout in Healthy Volunteers

Completed Phase 1 Last updated 23 May 2024

What this trial tests

Phase 1 trial testing EcN Colibactin knockout in Diabetes in 20 participants. Completed in 19 March 2024.

Timeline

18 September 2023

Primary endpoint
19 March 2024

19 March 2024

Quick facts

Lead sponsor	Max Nieuwdorp
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	18 September 2023
Primary completion	19 March 2024
Estimated completion	19 March 2024
Sites	1 location across Netherlands

Drugs / interventions tested

EcN Colibactin knockout
E Coli Nissle

Conditions studied

Diabetes — all drugs for Diabetes →

Sponsor

Max Nieuwdorp

Who can join

Adults 18 to 65, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

E. coli Nissle (EcN) is a well-established human probiotic. However, it has been found that it produces colibactin, linked to colorectal cancer. In this safety trial, the safety and properties of a novel, colibactin-knockout EcN strain (EcNΔClbP) is investigated.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Benefits and concerns of probiotics: an overview of the potential genotoxicity of the colibactin-producing <i>Escherichia coli</i> Nissle 1917 strain.
Falzone L, Lavoro A, Candido S, Salmeri M, et al · · 2024 · cited 11× · PMID 39229962 · DOI 10.1080/19490976.2024.2397874

Verify or expand the search:

Other recruiting trials for Diabetes

Currently open trials in the same condition.

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NCT07479134 — Production of Stem Cells for the Generation of Pancreatic Cells · NA · recruiting
NCT07441655 — Families Implementing Good Health Traditions for Life · NA · recruiting
NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
NCT07417865 — ECHO Diabetes FQHC · recruiting

Other Max Nieuwdorp trials

Trials by the same sponsor.

NCT06502834 — Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023) · Phase 1 · 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 NCT05816577 (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 Max Nieuwdorp
Last refreshed: 23 May 2024

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/NCT05816577.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing