NCT02390232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

February 25, 2015

Last Update Submit

August 13, 2018

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

gut microbiotaNon Alcoholic Steato HepatitisSteatohepatitisEscherichia colicolibactin

Outcome Measures

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.

    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.

    1 day

Secondary Outcomes (3)

  • differences between the two groups

    1 day

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

    1 day

  • Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients

    1 day

Study Arms (2)

NAFLD with simple steatosis

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

Biological: liver biopsyBiological: collection of stoolsBiological: blood sample

NAFLD with steatohepatitis

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

Biological: liver biopsyBiological: collection of stoolsBiological: blood sample

Interventions

liver biopsyBIOLOGICAL

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

NAFLD with simple steatosisNAFLD with steatohepatitis
collection of stoolsBIOLOGICAL

collection of stools

NAFLD with simple steatosisNAFLD with steatohepatitis
blood sampleBIOLOGICAL

collection of blood sample

NAFLD with simple steatosisNAFLD with steatohepatitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Non Alcoholic Fatty Liver Disease

You may qualify if:

  • NAFLD
  • indication of liver biopsy

You may not qualify if:

  • 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
  • chronic gastrointestinal disease or history of gastrointestinal surgery
  • pregnancy or breastfeeding
  • patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

  • Smati S, Polizzi A, Fougerat A, Ellero-Simatos S, Blum Y, Lippi Y, Regnier M, Laroyenne A, Huillet M, Arif M, Zhang C, Lasserre F, Marrot A, Al Saati T, Wan J, Sommer C, Naylies C, Batut A, Lukowicz C, Fougeray T, Tramunt B, Dubot P, Smith L, Bertrand-Michel J, Hennuyer N, Pradere JP, Staels B, Burcelin R, Lenfant F, Arnal JF, Levade T, Gamet-Payrastre L, Lagarrigue S, Loiseau N, Lotersztajn S, Postic C, Wahli W, Bureau C, Guillaume M, Mardinoglu A, Montagner A, Gourdy P, Guillou H. Integrative study of diet-induced mouse models of NAFLD identifies PPARalpha as a sexually dimorphic drug target. Gut. 2022 Apr;71(4):807-821. doi: 10.1136/gutjnl-2020-323323. Epub 2021 Apr 26.

    PMID: 33903148DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

feces, liver, blood

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty LiverEscherichia coli Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Maeva Guillaume, Doctor

    CHU de Toulouse, hôpital Purpan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 17, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)