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

Non-alcoholic Fatty Liver Disease Clinical Trial

— Coli-NASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390232
• Other study ID #: RC31/14/7319
• Status: Completed
• Start date: February 2015
• Est. completion date: November 2017

Study information

• Verified date: August 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Biological:
• liver biopsy
A small needle is inserted into the liver to collect a tissue sample
• collection of stools
collection of stools
• blood sample
collection of blood sample

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composition of the gut microbiota between two groups, and prevalence of the Escherichia Coli belonging to the B2 group and producing the genotoxin colibactin.	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.	1 day
Secondary	differences between the two groups	highlight other differences between the two cohort	1 day
Secondary	determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver	determine if bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver	1 day
Secondary	Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients	Determination of bacterial translocation assay PCR 16S bacterial gene in blood and sequence and analyse the microbiota.	1 day