Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT04781933
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Follow up of Biological Scores (FIB4, NAFLD) throughout the study', 'timeFrame': 'At 6 months'}, {'measure': 'Follow up of symbiosis throughout the study, analysis of stool of the microbiota and measurement of the biological parameters of the symbiosis; correlation with the evolution of NASH.', 'timeFrame': 'At 6 months'}, {'measure': 'Follow up of metabolic syndrome settings throughout the study : weight, waistline, blood pressure, Glycemia, Insulinemia, Gycated Hemoglonin level, Ferritinaemia, Triglyceridemia, HDL Cholesterol, LDL Cholesterol, Apolipoproteine A1, Homa score.', 'timeFrame': 'At 6 months'}], 'primaryOutcomes': [{'measure': 'NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis', 'timeFrame': 'At 6 months', 'description': 'Evolution of the SAF score and CAP elastometry, a composite histological score taking into account the improvement of Steatosis, histological activity and liver fibrosis'}], 'secondaryOutcomes': [{'measure': 'Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).', 'timeFrame': 'At the screening'}, {'measure': 'Follow up of transaminase levels', 'timeFrame': 'At 6 months'}, {'measure': 'Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI', 'timeFrame': 'At 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Combo', 'liver stiffness', 'gut microbiota', 'dietary supplements'], 'conditions': ['NASH - Nonalcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.', 'detailedDescription': 'Liver-related mortality is increased 10-fold in NASH patients compared with the general population. Currently, there are no established pharmacotherapies for NASH patients. The gut microbiota has a major contributing role in the development of NASH with leaky gut, inflammation, oxidative stress and impaired microbiota. Restoring the microbiota symbiosys could be a new way of resolution of NASH.\n\nThe aim of this trial is to evaluate the efficacy of the Combo, association of probiotics (Lactobacillus rhamnosus GG, Bifidobacterium breve BR03, Lactobacillus plantarum) and Glutamine, Quercetin, Vitamin E, Curcumin, Silybin, Pectin by means of histological resolution of NASH without progression of fibrosis, after 26 weeks (6 months), in 60 NASH patients with mild to severe fibrosis.\n\nTo confirm a histological diagnosis of NASH and proof efficacy of the Combo, a liver biopsy will be performed prior to screening as well as at the end of supplemental phase'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of moderate to severe NASH :\n\n * chronic liver disease: biological abnormalities for more than 6 months characteristic ultrasound aspects\n * metabolic syndrome\n * liver stiffness assessed by FibroScan between 8 and 15kPa\n* Adults\n* Affiliated to a social security\n* Women using effective contraception (hormonal or mechanical) for the duration of the srudy\n\nExclusion Criteria:\n\n* Pregnancy\n* Excessive alcohol consumption (\\>100g/week)\n* Cirrhosis (elastometry \\> 15kPa)\n* hepato-cellular carcinoma\n* Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen\n* Viral hepatitis\n* Auto immune hepatitis\n* anticoagulant therapy\n* antibiotics in the month prior to inclusion\n* allergic to soya, aspirin, fish, E110 dye, Maltodextrin\n* poorly controlled diabetes (Glycated Hemoglobin \\>8%)\n* inclusion in a drug interventional trial'}, 'identificationModule': {'nctId': 'NCT04781933', 'acronym': 'ICAN', 'briefTitle': 'Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mativa-Tech SA'}, 'officialTitle': 'Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement', 'orgStudyIdInfo': {'id': 'ICAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment with Combo', 'description': '3 dietary supplements will be given', 'interventionNames': ['Dietary Supplement: Treatment with Combo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment with Placebo', 'description': '3 placebos will be given', 'interventionNames': ['Other: Treatment with placebo']}], 'interventions': [{'name': 'Treatment with Combo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Treatment with Combo', 'armGroupLabels': ['Treatment with Combo']}, {'name': 'Treatment with placebo', 'type': 'OTHER', 'description': 'Treatment with placebo', 'armGroupLabels': ['Treatment with Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle ROSA, MD', 'role': 'CONTACT', 'email': 'isabelle.rosa@chicreteil.fr'}], 'facility': 'Centre Hospitalier Intercommunal Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94190', 'city': 'Villeneuve-Saint-Georges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Armand GARIOUD, PhD', 'role': 'CONTACT', 'email': 'armand.garioud@chiv.fr'}], 'facility': 'Centre Hospitalier Intercommunal de Villeneuve St Georges', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}], 'centralContacts': [{'name': 'Isabelle ROSA, Ph D', 'role': 'CONTACT', 'email': 'isabelle.rosa@chicreteil.fr', 'phone': '01 57 02 27 30'}, {'name': 'Luc LEITZ', 'role': 'CONTACT', 'email': 'luc.heitz@mativa-tech.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mativa-Tech SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pr', 'investigatorFullName': 'Hervé Hagege', 'investigatorAffiliation': 'Centre Hospitalier Intercommunal Creteil'}}}}