The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00068094

Purpose

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.

Condition	Intervention	Phase
Fatty Liver Hepatic Steatosis Diabetes Mellitus Liver Diseases	Drug: Probiotic-containing powder	Phase I Phase II

MedlinePlus related topics: Diabetes Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of a Probiotic on Hepatic Steatosis

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	30
Study Start Date:	July 2005
Estimated Study Completion Date:	February 2006

Detailed Description:

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.

Participants 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Nonalcoholic fatty liver disease

Exclusion Criteria:

Any cause of liver disease other than hepatic steatosis
Diabetes
Known or suspected cirrhosis
Inability or unwillingness to undergo magnetic resonance procedures
Requirement of long-term antibiotic therapy
Pregnancy, breast-feeding, or plans to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068094

Locations

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Steve Solga, MD

Johns Hopkins University

More Information

Publications:

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. No abstract available.

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.

Study ID Numbers:	R21 AT001305
Study First Received:	September 5, 2003
Last Updated:	August 16, 2006
ClinicalTrials.gov Identifier:	NCT00068094
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Probiotics
Bacteria

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic steatohepatitis (NASH)
Digestive System Diseases
Metabolic Diseases
Diabetes Mellitus

Endocrine System Diseases
Fatty Liver
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009