Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00068094
Status:
TERMINATED
Last Update Posted:
2006-08-18
First Post:
2003-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-07'}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2006-08-16', 'studyFirstSubmitDate': '2003-09-05', 'studyFirstSubmitQcDate': '2003-09-08', 'lastUpdatePostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Probiotics', 'Bacteria'], 'conditions': ['Fatty Liver', 'Hepatic Steatosis', 'Diabetes Mellitus', 'Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '12713883', 'type': 'BACKGROUND', 'citation': 'Solga SF, Diehl AM. Non-alcoholic fatty liver disease: lumen-liver interactions and possible role for probiotics. J Hepatol. 2003 May;38(5):681-7. doi: 10.1016/s0168-8278(03)00097-7. No abstract available.'}, {'pmid': '12540784', 'type': 'BACKGROUND', 'citation': 'Li Z, Yang S, Lin H, Huang J, Watkins PA, Moser AB, Desimone C, Song XY, Diehl AM. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003 Feb;37(2):343-50. doi: 10.1053/jhep.2003.50048.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether probiotics, bacteria that may improve liver health, can effectively treat a chronic condition in diabetics that increases fat in the liver.', 'detailedDescription': 'Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and is also common in diabetics; unfortunately, research on NAFLD has been limited. Safe, inexpensive, and well-tolerated treatments for NAFLD are needed. Recent studies indicate that probiotics help to improve fat breakdown in mice. This study will evaluate the efficacy of probiotic therapy to reduce fat accumulation in the livers of people with NAFLD and diabetes.\n\nParticipants in this study will be randomly assigned to receive either a probiotic-containing mixture or placebo once daily for 6 months. Blood tests, and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nonalcoholic fatty liver disease\n\nExclusion Criteria:\n\n* Any cause of liver disease other than hepatic steatosis\n* Diabetes\n* Known or suspected cirrhosis\n* Inability or unwillingness to undergo magnetic resonance procedures\n* Requirement of long-term antibiotic therapy\n* Pregnancy, breast-feeding, or plans to become pregnant'}, 'identificationModule': {'nctId': 'NCT00068094', 'briefTitle': 'The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'The Effect of a Probiotic on Hepatic Steatosis', 'orgStudyIdInfo': {'id': 'R21AT001305', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001305', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Probiotic-containing powder', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Steve Solga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}