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

Completed

• Conditions: Non-alcoholic Fatty Liver Disease

• Registration Number: NCT02390232
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 day	compare 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 Outcome Measures

Name	Time	Method
differences between the two groups	1 day	highlight other differences between the two cohort
determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver	1 day	determine if bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver
Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients	1 day	Determination of bacterial translocation assay PCR 16S bacterial gene in blood and sequence and analyse the microbiota.

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France