Safety and Viability of an E. coli Nissle Colibactin Knockout in Healthy Volunteers: A Randomised Controlled Safety Study

Completed

• Conditions: diabetes; Diabetes mellitus; 10018424; 10017943

• Registration Number: NL-OMON53774
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Healthy male or female of Caucasian descent
o 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 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. MDMA/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.
- Pregnancy or breast feeding
- Simultaneous participation in other studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the number, duration and severity of adverse reactions to<br /><br>assess the safety/tolerability of the EcN&Delta;ClbP strain compared to the wild type<br /><br>strain. In addition, changes in inflammatory markers (CRP, leukocytes) will be<br /><br>measured as well as blood safety parameters (liver and renal function, complete<br /><br>blood count, lipids and glucose/insulin) at V2, V3 and V4. Finally, quality of<br /><br>life, gastrointestinal (GI) comfort and stool metrics are recorded through<br /><br>validated questionnaires (gastro-intestinal quality of life, GIQLI, and<br /><br>Bristol Stool Chart) at V2, V3 and V4.</p><br>