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

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ClinicalTrials.gov Identifier: NCT02390232
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Non-alcoholic Fatty Liver Disease Biological: liver biopsy Biological: collection of stools Biological: blood sample

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 176 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH
Actual Study Start Date : February 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017


Group/Cohort Intervention/treatment
NAFLD with simple steatosis
Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy
Biological: liver biopsy
A small needle is inserted into the liver to collect a tissue sample

Biological: collection of stools
collection of stools

Biological: blood sample
collection of blood sample

NAFLD with steatohepatitis
Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy
Biological: liver biopsy
A small needle is inserted into the liver to collect a tissue sample

Biological: collection of stools
collection of stools

Biological: blood sample
collection of blood sample




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
feces, liver, blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Non Alcoholic Fatty Liver Disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390232


Locations
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France
CHU Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Maeva Guillaume, Doctor CHU de Toulouse, hôpital Purpan
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02390232    
Other Study ID Numbers: RC31/14/7319
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
gut microbiota
Non Alcoholic Steato Hepatitis
Steatohepatitis
Escherichia coli
colibactin
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases