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

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