Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- Biological: liver biopsyBiological: collection of stoolsBiological: blood sample
- Registration Number
- NCT02390232
- Lead Sponsor
- University Hospital, Toulouse
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- NAFLD
- indication of liver biopsy
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NAFLD with simple steatosis collection of stools Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy NAFLD with simple steatosis liver biopsy Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy NAFLD with simple steatosis blood sample Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy NAFLD with steatohepatitis collection of stools Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy NAFLD with steatohepatitis blood sample Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy NAFLD with steatohepatitis liver biopsy Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy
- Primary Outcome Measures
Name Time Method composition of the gut microbiota between two groups, and prevalence of the Escherichia Coli belonging to the B2 group and producing the genotoxin colibactin. 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 Outcome Measures
Name Time Method differences between the two groups 1 day highlight other differences between the two cohort
determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver 1 day determine if bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver
Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients 1 day Determination of bacterial translocation assay PCR 16S bacterial gene in blood and sequence and analyse the microbiota.
Trial Locations
- Locations (1)
CHU Toulouse
🇫🇷Toulouse, France