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

T

Toulouse University Hospital

Status

Completed

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Biological: liver biopsy
Biological: collection of stools
Biological: blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT02390232
RC31/14/7319

Details and patient eligibility

About

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.

Full 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.

Enrollment

176 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

176 participants in 2 patient groups

NAFLD with simple steatosis
Description:
Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy
Treatment:
Biological: collection of stools
Biological: liver biopsy
Biological: blood sample
NAFLD with steatohepatitis
Description:
Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy
Treatment:
Biological: collection of stools
Biological: liver biopsy
Biological: blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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