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NCT05816577 | Not yet recruiting | Diabetes

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

Max Nieuwdorp

Information provided by (Responsible Party):

Max Nieuwdorp

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.

Condition or disease

Diabetes

Intervention/treatment

EcN Colibactin knockout

E Coli Nissle

Phase

Phase 1

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.}}

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 : June 1, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024
Arm Intervention/treatment

Active Comparator: EcN

E Coli Nissle wildtype 10^11 once daily for 7 days

Dietary Supplement: E Coli Nissle

Experimental: EcN colibactin-knockout

EcN colibactin-knockout 10^11 once daily for 7 days

Dietary Supplement: EcN Colibactin knockout
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion criteria
  • Healthy male or female of Caucasian descent
  • If female, postmenopausal
  • Age: 18-65 years old
  • BMI: 18-25 kg/m2
  • Subjects should be able to give informed consent
Exclusion Criteria
  • Use of any systemic medication (except for paracetamol), including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period.
  • Use of the EcN probiotic strain (Mutaflor®) in the past 12 months.
  • (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4-T cell count < 240/mm3).
  • History of moderate to severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools/day for >4 weeks), chronic obstipation (<2 defecations/week for >3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
  • Any gastro-intestinal disorder within the past 6 months
  • Smoking or illicit drug use (e.g. amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
  • Use of >21 units of alcohol per week on average in the past three months or use of >2 units of alcohol during the study period.
  • Simultaneous participation in other studies
Safety and Viability of an E. Coli Nissle Colibactin Knockout in Healthy Volunteers

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

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Locations

Not yet recruiting

Netherlands,

Amsterdam UMC location AMC

Amsterdam, Netherlands,