Max Nieuwdorp
Max Nieuwdorp
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.
Diabetes
EcN Colibactin knockout
E Coli Nissle
PHASE1
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 20 participants |
Masking : | TRIPLE |
Masking Description : | Participants will be randomised through Castor (eCRF). Treatment allocation is blinded for investigators and participants. The pharmacist has access to the randomisation list. |
Primary Purpose : | TREATMENT |
Official Title : | Safety and Viability of an E. Coli Nissle Colibactin Knockout in Healthy Volunteers |
Actual Study Start Date : | 2023-09-18 |
Estimated Primary Completion Date : | 2024-03-19 |
Estimated Study Completion Date : | 2024-03-19 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Amsterdam UMC location AMC
Amsterdam, Netherlands,