A Phase 1 interventional study of EcN Colibactin knockout and E Coli Nissle in Diabetes, sponsored by Max Nieuwdorp. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Max Nieuwdorp · Phase 1, Interventional, and Treatment
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.
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.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Max Nieuwdorp is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy male or female of Caucasian descent
Exclusion Criteria:
E Coli Nissle wildtype 10\^11 once daily for 7 days
Dietary Supplement: E Coli Nissle
EcN colibactin-knockout 10\^11 once daily for 7 days
Dietary Supplement: EcN Colibactin knockout
E coli Nissle strain with ClbP-gene removed and therefore not producing colibactin
E Coli wildtype strain
Adverse events
The number, duration and severity of adverse reactions to assess the safety/tolerability of the EcNΔClbP strain compared to the wild type strain.
Time frame: 3 weeks
CRP
Changes in CRP (mg/L)
Time frame: Weekly, during 3 weeks
Leucocytes
Changes in leucocytes (10\^9/L)
Time frame: Weekly, during 3 weeks
Renal function
Changes in renal function, expressed as kreatinin levels (micromol/L) throughout the study
Time frame: Weekly, during 3 weeks
Bilirubin
Changes in bilirubin in micromol/L throughout the study
Time frame: Weekly, during 3 weeks
alkaline phosphatase
Changes in alkaline phosphatase in U/L throughout the study
Time frame: Weekly, during 3 weeks
gamma-GT in U/L
Changes in gamma-GT in U/L throughout the study
Time frame: Weekly, during 3 weeks
AST
Changes in AST in U/L throughout the study
Time frame: Weekly, during 3 weeks
ALT
Changes in ALT in U/L throughout the study
Time frame: Weekly, during 3 weeks
Hemoglobin
Changes in hemoglobin in mmol/L throughout the study
Time frame: Weekly, during 3 weeks
trombocytes
Changes in trombocytes in 10\^9/L throughout the study
Time frame: Weekly, during 3 weeks
eosinophils
Changes in eosinophils in 10\^9/L throughout the study
Time frame: Weekly, during 3 weeks
basophils
Changes in basophils in 10\^9/L throughout the study
Time frame: Weekly, during 3 weeks
neutrophils
Changes in neutrophils in 10\^9/L throughout the study
Time frame: Weekly, during 3 weeks
monocytes
Changes in monocytes in 10\^9/L throughout the study
Time frame: Weekly, during 3 weeks
Lipid profile
Changes in lipid profile throughout the study
Time frame: Weekly, during 3 weeks
Homeostatic model of insulin resistance (HOMA-IR)
Changes in HOMA-IR throughout the study
Time frame: Weekly, during 3 weeks
Gastro-intestinal quality of life - questionnaire
Changes in Gastro-intestinal quality of life (GIQLI) score. The maximum score is 155, the minimum score is 31. A higher score represents a better outcome.
Time frame: Weekly, during 3 weeks
Bristol Stool Chart
Changes in Bristol Stool Chart score throughout the study. Stools can be scored from 1 (hard stool) to 7 (watery stool). A score of 4 is considered ideal.
Time frame: Weekly, during 3 weeks
Number of copies of EcN (qPCR)
Quantification of EcN in faeces samples collected throughout the two weeks via quantitative polymerase chain reaction (qPCR)
Time frame: Daily during 2 weeks
Microbiome composition
Comparison of relative abundances of species throughout the study using shotgun metagenomics
Time frame: Weekly during 3 weeks
Fecal 24h bile acids
Changes in 24h faecal bile acids will be measured at V2, V3 and V4.
Time frame: Weekly during 3 weeks
Fasting blood bile acids
Changes in fasting plasma bile acids will be measured at V2, V3 and V4.
Time frame: Weekly during 3 weeks
Fecal 24h short chain fatty acids
Changes in 24h faecal and fasting and short-chain fatty acids will be measured at V2, V3 and V4.
Time frame: Weekly during 3 weeks
Fasting blood short chain fatty acids
Changes in fasting short-chain fatty acids will be measured at V2, V3 and V4.
Time frame: Weekly during 3 weeks
Plan to share: No
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