Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02390232
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D004927', 'term': 'Escherichia coli Infections'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'feces, liver, blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '1 day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'differences between the two groups', 'timeFrame': '1 day', 'description': 'highlight other differences between the two cohort'}, {'measure': 'determine wether bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver', 'timeFrame': '1 day', 'description': 'determine if bacteria, in particular escherichia Coli can translocate and reach steatohepatitis patients liver'}, {'measure': 'Exploration of a biomarker of fibrosis from blood microbiota in NAFLD patients', 'timeFrame': '1 day', 'description': 'Determination of bacterial translocation assay PCR 16S bacterial gene in blood and sequence and analyse the microbiota.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gut microbiota', 'Non Alcoholic Steato Hepatitis', 'Steatohepatitis', 'Escherichia coli', 'colibactin'], 'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '33903148', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Non Alcoholic Fatty Liver Disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NAFLD\n* indication of liver biopsy\n\nExclusion Criteria:\n\n* presence of any other cause of liver or steatosis\n* alcohol consumption exceeding 30 g / day for a men and 20 g / day for a woman\n* a history of decompensated cirrhosis\n* treatment with prebiotics, probiotics or antibiotics in the month prior to inclusion\n* chronic gastrointestinal disease or history of gastrointestinal surgery\n* pregnancy or breastfeeding\n* patient under guardianship'}, 'identificationModule': {'nctId': 'NCT02390232', 'acronym': 'Coli-NASH', 'briefTitle': 'Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH', 'orgStudyIdInfo': {'id': 'RC31/14/7319'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NAFLD with simple steatosis', 'description': 'Patients with NAFLD with simple steatosis: collection of stools, blood sample and liver biopsy', 'interventionNames': ['Biological: liver biopsy', 'Biological: collection of stools', 'Biological: blood sample']}, {'label': 'NAFLD with steatohepatitis', 'description': 'Patients with NAFLD with steatohepatitis: collection of stools, blood and liver biopsy', 'interventionNames': ['Biological: liver biopsy', 'Biological: collection of stools', 'Biological: blood sample']}], 'interventions': [{'name': 'liver biopsy', 'type': 'BIOLOGICAL', 'description': 'A small needle is inserted into the liver to collect a tissue sample', 'armGroupLabels': ['NAFLD with simple steatosis', 'NAFLD with steatohepatitis']}, {'name': 'collection of stools', 'type': 'BIOLOGICAL', 'description': 'collection of stools', 'armGroupLabels': ['NAFLD with simple steatosis', 'NAFLD with steatohepatitis']}, {'name': 'blood sample', 'type': 'BIOLOGICAL', 'description': 'collection of blood sample', 'armGroupLabels': ['NAFLD with simple steatosis', 'NAFLD with steatohepatitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Maeva Guillaume, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Toulouse, hôpital Purpan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}