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Completed

NCT Number: NCT02390232

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

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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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Enterobacteriaceae Infections Escherichia coli Infections Fatty Liver Gram-Negative Bacterial Infections Infections Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver biopsy

Biological

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

collection of stools

Biological

collection of stools

Blood sample

Biological

collection of blood sample

Primary outcomes

  1. composition of the gut microbiota between two groups, and prevalence of the Escherichia Coli belonging to the B2 group and producing the genotoxin colibactin.

    Time frame: 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 outcomes

  1. differences between the two groups

    Time frame: 1 day

    highlight other differences between the two cohort

  2. determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver

    Time frame: 1 day

    determine if bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver

  3. Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients

    Time frame: 1 day

    Determination of bacterial translocation assay PCR 16S bacterial gene in blood and sequence and analyse the microbiota.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: Coli-NASH

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2015
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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