Non-alcoholic Fatty Liver DiseaseColi-NASHNCT02390232
Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH
An observational study of Non-alcoholic Fatty Liver Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- liver biopsy, collection of stools and blood sample
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Nov 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Non Alcoholic Fatty Liver Disease
Who may be able to join
- NAFLD
- indication of liver biopsy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- liver biopsy, collection of stools, blood sample
- Keywords
- gut microbiota, Non Alcoholic Steato Hepatitis, Steatohepatitis, Escherichia coli, colibactin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver biopsyBiological
A small needle is inserted into the liver to collect a tissue sample
collection of stoolsBiological
collection of stools
blood sampleBiological
collection of blood sample
| Study group | Role | What they receive |
|---|---|---|
| NAFLD with simple steatosis | Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy Receives: Biological: liver biopsy; Biological: collection of stools; Biological: blood sample | |
| NAFLD with steatohepatitis | Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy Receives: Biological: liver biopsy; Biological: collection of stools; Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
differences between the two groups
highlight other differences between the two cohort
Measured: 1 day
determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver
determine if bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver
Measured: 1 day
Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients
Determination of bacterial translocation assay PCR 16S bacterial gene in blood and sequence and analyse the microbiota.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maeva Guillaume, Doctor, Principal investigator, CHU de Toulouse, hôpital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390232
- Sponsor's protocol ID
- RC31/14/7319
- Acronym
- Coli-NASH
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2015
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33903148
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH
- ClinicalTrials.gov ID
- NCT02390232
- Acronym / sponsor ID
- Coli-NASH / RC31/14/7319
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- gut microbiota, Non Alcoholic Steato Hepatitis, Steatohepatitis, Escherichia coli, colibactin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD with simple steatosis | – | Biological: liver biopsy, Biological: collection of stools, Biological: blood samplePatients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy |
| NAFLD with steatohepatitis | – | Biological: liver biopsy, Biological: collection of stools, Biological: blood samplePatients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Non Alcoholic Fatty Liver Disease
Key inclusion criteria (2 listed)
- NAFLD
- indication of liver biopsy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver biopsyA small needle is inserted into the liver to collect a tissue sample | Biological | NAFLD with simple steatosis, NAFLD with steatohepatitis |
| collection of stoolscollection of stools | Biological | NAFLD with simple steatosis, NAFLD with steatohepatitis |
| blood samplecollection of blood sample | Biological | NAFLD with simple steatosis, NAFLD with steatohepatitis |
Primary outcome
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.
3 secondary outcomes
differences between the two groups
Time frame: 1 day
determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver
Time frame: 1 day
Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 33903148Smati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maeva Guillaume, Doctor principal investigator
CHU de Toulouse, hôpital Purpan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.