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Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH

Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02390232
Acronym
Coli-NASH
Enrollment
176
Registered
2015-03-17
Start date
2015-02-28
Completion date
2017-11-30
Last updated
2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

gut microbiota, Non Alcoholic Steato Hepatitis, Steatohepatitis, Escherichia coli, colibactin

Brief summary

In a population of patients with Non Alcoholic Fatty Liver Disease (NAFLD), the investigators will compare the composition of the gut microbiota from patients with simple steatosis with that with steatohepatitis. The purpose of this study is to determine if the pathogenic Escherichia Coli to the B2 group and producing the genotoxin colibactin is a factor for developing NASH.

Detailed description

Gut microbiota composition is now linked to the onset of obesity, metabolic disorders, and Non Alcoholic Fatty Liver Disease . While simple steatosis has benign prognosis, steatohepatitis (NASH) leads to cirrhosis and hepatocarcinoma and increases cardiovascular and cancer- related mortality. Some Escherichia coli (E. coli) belonging to the B2 phylogenetic group are involved in many diseases. Those producing the genotoxin colibactin are in addition known to induce a chronic alteration of intestinal permeability, one of the major factors leading to NASH.

Interventions

BIOLOGICALliver biopsy

A small needle is inserted into the liver to collect a tissue sample

BIOLOGICALcollection of stools

collection of stools

BIOLOGICALblood sample

collection of blood sample

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* NAFLD * indication of liver biopsy

Exclusion criteria

* presence of any other cause of liver or steatosis * alcohol consumption exceeding 30 g / day for a men and 20 g / day for a woman * a history of decompensated cirrhosis * treatment with prebiotics, probiotics or antibiotics in the month prior to inclusion * chronic gastrointestinal disease or history of gastrointestinal surgery * pregnancy or breastfeeding * patient under guardianship

Design outcomes

Primary

MeasureTime frameDescription
composition of the gut microbiota between two groups, and prevalence of the Escherichia Coli belonging to the B2 group and producing the genotoxin colibactin.1 daycompare the composition of the gut microbiota between patients with simple steatosis with steatohepatitis, and determinate the prevalence of the Escherichia Coli belonging to the B2 group and producing the genotoxin colibactin.

Secondary

MeasureTime frameDescription
differences between the two groups1 dayhighlight other differences between the two cohort
determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver1 daydetermine if bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver
Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients1 dayDetermination of bacterial translocation assay PCR 16S bacterial gene in blood and sequence and analyse the microbiota.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026