NCT05816577

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Max Nieuwdorp · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

In this randomised controlled intervention study, the investigators will compare EcN vs. EcN colibactin-knockout (EcNΔClbP), given once daily for 7 days, in a population of healthy individuals. Safety will be established using adverse event reporting, study visits and laboratory parameters. Pharmacokinetics will be established at the beginning and the end of the study. EcN/EcNΔClbP gut engraftment properties and effects on gut microbiome composition will be assessed using fecal analyses (qPCR, shotgun metagonmics). In addition, effects on glucose homeostasis will be studied using continuous glucose monitoring.

Conditions

• Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EcN Colibactin knockout	E coli Nissle strain with ClbP-gene removed and therefore not producing colibactin
DIETARY_SUPPLEMENT	E Coli Nissle	E Coli wildtype strain

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-03-19
• Completion: 2024-03-19
• First posted: 2023-04-18
• Last updated: 2024-05-23

Locations

1 site across 1 country: Netherlands