Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT01791959
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
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': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alaninaminotransferase (ALT)', 'timeFrame': '28 weeks'}, {'measure': 'Liver fibrosis', 'timeFrame': '28 weeks'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '28 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non Alcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '24401715', 'type': 'DERIVED', 'citation': 'Eslamparast T, Poustchi H, Zamani F, Sharafkhah M, Malekzadeh R, Hekmatdoost A. Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study. Am J Clin Nutr. 2014 Mar;99(3):535-42. doi: 10.3945/ajcn.113.068890. Epub 2014 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of 18 to 70 years\n* Body Mass Index (BMI) between 25-40\n* Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range\n* Sonographic findings compatible with hepatic steatosis (degree 2 or more)\n\nExclusion Criteria:\n\n* Diabetes\n* Taking any kind of antibiotics two weeks before recruitment\n* History of alcohol consumption\n* pregnancy or lactation\n* Professional athletes\n* Other liver disease (viral/etc)\n* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E\n* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \\& Celiac disease; Cirrhosis\n* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty\n* Following program to lose weight in recent 3 mo\n* A history of hypothyroidism or Cushing's syndrome"}, 'identificationModule': {'nctId': 'NCT01791959', 'briefTitle': 'The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis', 'orgStudyIdInfo': {'id': '046466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synbiotic', 'description': '2 synbiotic capsules for 28 weeks', 'interventionNames': ['Dietary Supplement: synbiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'maltodexterin', 'description': 'two capsules per day for 28 weeks', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'synbiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 symbiotics capsules per day for 28 weeks', 'armGroupLabels': ['Synbiotic']}, {'name': 'placebo', 'type': 'OTHER', 'description': '2 Maltodexterin capsules as a placebo per day for 28 weeks', 'armGroupLabels': ['maltodexterin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Azita Hekmatdoost, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Nutrition and Food Technology Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}