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

NCT05816577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Max Nieuwdorp

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2024-03-19
Completion
2024-03-19

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05816577 on ClinicalTrials.gov