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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-11-30

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.

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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.

Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NAFLD with simple steatosis

Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy

liver biopsy

Intervention Type BIOLOGICAL

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

collection of stools

Intervention Type BIOLOGICAL

collection of stools

blood sample

Intervention Type BIOLOGICAL

collection of blood sample

NAFLD with steatohepatitis

Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy

liver biopsy

Intervention Type BIOLOGICAL

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

collection of stools

Intervention Type BIOLOGICAL

collection of stools

blood sample

Intervention Type BIOLOGICAL

collection of blood sample

Interventions

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liver biopsy

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

Intervention Type BIOLOGICAL

collection of stools

Intervention Type BIOLOGICAL

blood sample

collection of blood sample

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No