Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-02-01 @ 11:59 AM
Study NCT ID:
NCT02335632
Status:
UNKNOWN
Last Update Posted:
2015-01-28
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-02-24', 'releaseDate': '2016-01-28'}, {'resetDate': '2016-06-02', 'releaseDate': '2016-04-27'}, {'resetDate': '2018-07-19', 'releaseDate': '2018-06-24'}, {'resetDate': '2020-08-20', 'releaseDate': '2020-08-10'}], 'estimatedResultsFirstSubmitDate': '2016-01-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2015-01-09', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'liver enzymes', 'timeFrame': '7 days after probiotics'}], 'secondaryOutcomes': [{'measure': 'LPS and pro-inflammatory cytokines', 'timeFrame': '7 days after probiotics'}, {'measure': 'Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis', 'timeFrame': '7 days after probiotics'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis', 'Probiotics', 'Lipopolysaccharides', 'Cytokines', 'Alcoholics'], 'conditions': ['Alcoholic Liver Disease']}, 'descriptionModule': {'briefSummary': 'Background/Aims:\n\nThe investigators explored the therapeutic effects of probiotics in patients with AH.\n\nMethods:\n\nBetween December 2012 and January 2015, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \\> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.', 'detailedDescription': 'Background/Aims: Alcoholic hepatitis (AH) is one of the leading causes of liver diseases. Gut-derived microbial lipopolysaccharide (LPS) has been known as a central role in the pathogenesis of AH. Some animal studies suggested an emerging role of probiotics in restoration of the bowel flora and improving liver enzymes. We explored the therapeutic effects of probiotics in patients with AH.\n\nMethods:\n\nBetween December 2012 and January 2015, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \\> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alcoholic hepatitis (AST/ALT \\>2 \\& elevated AST (ALT) level\n* Alcohol \\>60 g/day (M), \\>40 g/day (F) during 7 days before screening\n* Last drinks: within 48 hours prior to admission)\n\nExclusion Criteria:\n\n* viral hepatitis,\n* autoimmune hepatitis,\n* pancreatitis,\n* hemochromatosis,\n* Wilson's disease,\n* Drug-Induced Liver Injury,\n* cancer,\n* infection need for antibiotics,\n* severe AH, or\n* obesity (BMI \\>30 kg/m2)"}, 'identificationModule': {'nctId': 'NCT02335632', 'briefTitle': 'Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis', 'orgStudyIdInfo': {'id': 'EPAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'For Probiotics, 7 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'description': 'Probiotics of 120 mg/day for 7days', 'interventionNames': ['Drug: Probiotics (Lacidofil®)']}], 'interventions': [{'name': 'Probiotics (Lacidofil®)', 'type': 'DRUG', 'otherNames': ['Lacidofil®'], 'description': '7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['For probiotics'], 'description': 'For probiotics', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Internal Medicine', 'investigatorFullName': 'Ki Tae Suk', 'investigatorAffiliation': 'Chuncheon Sacred Heart Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-01-28', 'type': 'RELEASE'}, {'date': '2016-02-24', 'type': 'RESET'}, {'date': '2016-04-27', 'type': 'RELEASE'}, {'date': '2016-06-02', 'type': 'RESET'}, {'date': '2018-06-24', 'type': 'RELEASE'}, {'date': '2018-07-19', 'type': 'RESET'}, {'date': '2020-08-10', 'type': 'RELEASE'}, {'date': '2020-08-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ki Tae Suk, Department of Internal Medicine, Chuncheon Sacred Heart Hospital'}}}}