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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Biological: liver biopsy
* Biological: collection of stools
* Biological: blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NAFLD with simple steatosis<br>Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy | Biological: liver biopsy<br>* A small needle is inserted into the liver to collect a tissue sample<br>Biological: collection of stools<br>* collection of stools<br>Biological: blood sample<br>* collection of blood sample<br>|
| NAFLD with steatohepatitis<br>Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy | Biological: liver biopsy<br>* A small needle is inserted into the liver to collect a tissue sample<br>Biological: collection of stools<br>* collection of stools<br>Biological: blood sample<br>* collection of blood sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences between the two groups | highlight other differences between the two cohort | 1 day | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, Non Alcoholic Steato Hepatitis, Steatohepatitis, Escherichia coli, colibactin