Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816577
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2023-03-09
Brief Title:
Safety and Viability of an E Coli Nissle Colibactin Knockout in Healthy Volunteers
Sponsor:
Max Nieuwdorp
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Safety and Viability of an E Coli Nissle Colibactin Knockout in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SECONI
Brief 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 EcNEcNΔClbP 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None